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DR./ADEL ELNAGGAR
Endocrinologist
Ain Shams University, EGYPT.
Postgraduate Diabetes, UK.
Dr.Erfan & Bagedo Hospital
diabetes
&
Ramadan
DIABETES SPOT LIGHTS
RAMDAN & DIABETES
NOVEL PREMIX INSULIN
TOPICS
Risk Factors
• Obesity
• Race
• History of CVD
• HTN
• Physical inactivity
• Familial history
• Polycystic Ovary Syndrome
• Gestational Diabetes
? ? ? ? ? ? ?
(LACK OF DIABETES PYRAMID
STRATEGIES):
BASE: Early detection; diagnosis &
prevention Programs (Health
Education).
BODY: Proper scientific socio-economic
Management (Qualified Health Care
Providers).
TOP: Delay or prevent Diabetic
Complications (Reduce Morbidity &
Mortality).
SAUDI ARABIA
1 IN 4
PANCREAS
HORMONES:
INSULIN BY BETA CELLS
GLUCAGON BY ALPHA CELLS
Review of Anatomy and Physiology
• Pancreas secretes 40-50
units of insulin daily in two
steps:
• Secreted at low levels
during fasting ( basal
insulin secretion)
• Increased levels after
eating (prandial)
• An early burst of insulin
occurs within 10 minutes of
eating
• Then proceeds with
increasing release as long
as hyperglycemia is present
Insulin
• Insulin allows glucose to
move into cells to make
energy
• Inhibits glucagon activity
Action of Insulin on Carbohydrate,
Protein and Fat Metabolism
•Carbohydrate
• Facilitates the transport of glucose into
muscle and adipose cells
• Facilitates the conversion of glucose to
glycogen for storage in the liver and muscle.
• Decreases the breakdown and release of
glucose from glycogen by the liver
Action of Insulin on Carbohydrate,
Protein and Fat Metabolism
•Fat
• Stimulates lipogenesis- the transport of
triglycerides to adipose tissue
• Inhibits lipolysis – prevents excessive
production of ketones or ketoacidosis
Action of Insulin on Carbohydrate,
Protein and Fat Metabolism
•Protein
• Stimulates protein synthesis
• Inhibits protein breakdown; diminishes
gluconeogenesis
What goes wrong in diabetes?
• Multitude of mechanisms
• Insulin
• Regulation
• Secretion
• Uptake or breakdown
• Beta cells
• damage
Pre-Diabetes
•Impaired fasting glucose (IFG)
•FPG- 100-125mg/dL
•Impaired glucose tolerance (IGT)
•OGTT 140-199mg/dL
•HbA1c 6-6.5%
Insulin resistance
metabolic syndrome
adults obese
Central obesity (waist circumference)
IGT or IFG
High lipid profile
LDL-HDL/CHOLESTEROL/TRIGLYCERIDES
HIGH BP more than 130/90
MANAGEMENT OF DIABETES
Life style modification
Diet
Exrcise
Psychological support
MANAGEMENT OF DIABETES
METFORMIN
DPP4
PIOGLTAZONES
GLP1 ANALOUGES
SGLT2 INHIBITORS
SUs
INSULINs
PANCREATIC TRANSPLANTION
STEM CELLS
METABOLIC SURGERIES
LETHAL
WEAPON
• Islamic holy month
where fasting is compulsory for all healthy
Muslims
• Absolute fast
between sunrise and sunset.
• Muslims fast from:
• Food
• Liquids
• Medication
Ramadan
• Children
• Elderly
• Sick
• Pregnant or nursing mothers
• Menstruating women
• People with chronic illness
(e.g. DM, CKD, CVD)
• Which Patients with
DIABETES
are Exempt from Fasting during
RAMADAN???
Patients With High Risk Of Complications.
Many Muslims with diabetes
insist on fasting during Ramadan.
This creates a medical challenges for both
patients and physicians.
Al-Arouj et al. Diabetes Care 2005;28:2305–11
Salti et al. Diabetes Care 2004;27:2306–11
CNS, central nervous system; GI, gastrointestinal; T2DM, type 2 diabetes mellitus
Cernea S & Raz I. Diabetes Care 2011;34(suppl 2):S264–S271
Adipocyte
CNS
Incretin
deficiency
GI tract
Altered fat
metabolism
INSULIN
RESISTANCE
INADEQUATE
INSULIN
SECRETION
↑ HEPATIC
GLUCOSE
PRODUCTION
↑ BLOOD GLUCOSE
Hyperglucagonaemia
↑ hepatic sensitivity
to glucagon
 cells
Îą cells
Skeletal
Muscle
Pancreas
Muscle
Kidney
Enhanced glucose
reabsorption
Pathophysiology Of Type 2 DIABETES
body glucose, which is stored in the liver and muscles, is
the body’s main source of energy.
Early In The Fast ; this store of glucose is used up first
to provide energy.
Later In The Fast ; once the stores of glucose run out,
fat becomes the next store source of energy for the
body.Mahroof,Ramadan Health Guide : a guide to healthy fasting ,Department of Health ,Sept,2007
Physiological Changes
That Occur During A Fast
In The Normal State
During A Fast
 Type 1 Diabetes
 Severe Hypoglycaemia Or
Ketoacidosis Within Last
Three Months Prior To
Ramadan
 Recurrent Hypoglycaemia
 Sustained Poor Glycaemic
Control
 Acute Illness
 Pregnancy
 Type 2 diabetes
 Moderate hyperglycaemia
 Renal insufficiency
 Advanced macro vascular
complications
 Living alone and treated with
sulphonylurea or insulin
 Comorbid conditions that
present additional risk factors
Al-Arouj et al. Diabetes Care 2005;28:2305–11
Patients at HIGH RISK
of developing COMPLICATIONS during Ramadan
VERY HIGH RISK HIGH RISK
Salti et al. Diabetes Care 2004;27:2306–11
• AIM:
to study diabetes during Ramadan and investigate the
effects of fasting
• Population:
12,243 Muslim patients with diabetes in 13 countries
• Demographics:
Demographics
Type 1
diabetes
Type 2
diabetes
Number 1070 11,173
Male/Female (%) 50/50 49/51
Age (years)* 31 (12.7) 54 (11.0)
Duration of diabetes (years)* 10 (7.6) 7.6 (5.8)
*Data are mean (SD)
Percentage of patients
reported fasting at
least 15 days:
type 1 – 42.8%
type 2 – 78.7%
Epidemiology of DIABETES and Ramadan
(EPI-DIA-R) study
Proportionofpatients(%)
Type 1 diabetes
(n=899)
Type 2 diabetes
(n=9775)
Body weight changes during Ramadan
Adapted from Salti et al. Diabetes Care 2004;27:2306–11
EPIDIAR study - Results
Proportionofpatients(%)
Changes in medication during
Ramadan
Type 1 diabetes Type 2 diabetes
Insulin dose
(n=980)
OAD dose
(n=94)
Insulin dose
(n=1831)
OAD dose
(n=9476)
Adapted from Salti et al. Diabetes Care 2004;27:2306–11
EPIDIAR study - Results
OAD, oral anti-diabetic drug
Numberofeventspermonth
Type 1 diabetes Type 2 diabetes
Severe hyperglycaemia with or without
ketoacidosis in patients who fasted ≥15 days
0.00
0.04
0.08
0.12
0.16
0.20
Before Ramadan During Ramadan
p=0.0015
Adapted from Salti et al. Diabetes Care 2004;27:2306–11
p=0.67
EPIDIAR study - Results
Type 1 diabetes Type 2 diabetes
Before
Ramadan
During
Ramadan
p-value
Before
Ramadan
During
Ramadan
p-value
Overall population 0.03 0.14 0.0174 0.004 0.03 <0.0001
Patients who fasted
≥15 days
0.02 0.12 0.9896 0.003 0.02 0.0015
Number of severe hypoglycaemic events during
Ramadan (number per month)
Data (except p values) are mean
Adapted from Salti et al. Diabetes Care 2004;27:2306–11
4.5 Folds 7.5 Folds
6 Folds 6.5 Folds
EPIDIAR study - Results
Al-Arouj et al. Diabetes Care 2005;28:2305–11
E Hui et al. BMJ 2010;340:1407–11
RECOMMENDATIONS
• Individualisation
• Patient specific recommendations
• Frequent monitoring of glycaemia
• Crucial for patients with type 1 diabetes and patients with
type 2 diabetes who require insulin treatment
• This will not break the fast
• Nutrition
• Healthy and balanced diet
• Ingesting large amount of foods rich in carbohydrate and
fat should be avoided
• Exercise
• Maintain normal levels of physical activity
• Breaking the fast
• Blood glucose <3.3 mmol/L or >16.7 mmol/L
Al-Arouj et al. Diabetes Care 2005;28:2305–11;
GENERAL CONSIDERATION & RULES
for
the management of DIABETES during RAMADAN
DIET-CONTROLLED PATIENTS
• Risk associated with fasting is low in patients who
are adequately controlled with diet alone
• Potential risk of postprandial hyperglycaemia if
patients overindulge in eating
• Daily exercise programme
may need to be modified to
avoid hypoglycaemia
• Fluid restrictions and
dehydration may increase
the risk of thrombosis
Al-Arouj et al. Diabetes Care 2005;28:2305–11
Management of patients
with TYPE 2 DIABETES during RAMADAN
Patients treated with oral agents
• METFORMIN
• Minimal possibility of hypoglycaemia
• Timing of doses should be modified
• ACARBOSE
• Continue with the prescribed doses
• taken only with meals
• GLITAZONES
• Low risk of hypoglycaemia
• No change in dose required
• SHORT-ACTING INSULIN SECRETAGOGUES
• Short duration of action
• Twice-daily dosing pre-meals
• SULPHONYLUREAS
• Increased risk of hypoglycaemia
Suitable for use
during Ramadan
Use with caution
during Ramadan
Al-Arouj et al. Diabetes Care 2005;28:2305–11 & E Hui et al. BMJ 2010;340:1407–11
Management of patients
with TYPE 2 DIABETES during RAMADAN
He Used To Worry
About Managing
His Diabetes During
Ramadan
Managing diabetes during Ramadan
can be challenging1
The majority of Muslim patients with
type 2 diabetes fast during Ramadan1
proper treatment adjustments,
including INSULIN REGIMEN, are
necessary to avoid HYPOGLYCAEMIA
and HYPERGLYCAEMIA2
1. Salti I et al. Diabetes Care 2004;27:2306–2311.
2. 2. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6):794–799.
NovoMixÂŽ 30
adds confidence to control
It Is Simple To Adjust NovomixŽ 30, During
Ramadan To Help Minimise The RISK Of
Hypoglycaemia Or Hyperglycaemia1
Flexible Mealtime Dosing – Patients Can Eat
Immediately After Injecting NovomixÂŽ 302
More Effective PPG Control And Lower Risk
Of Major And Nocturnal Hypoglycaemia* Vs
Human Premix Insulin3,4
1. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6):794–799.
2. NovoMixÂŽ 30 Summary of Product Characteristics.
3. Hermansen K et al. Diabetes Care 2002;25:883–888.
4. Davidson JA et al. Clin Ther 2009;31:1641–1651.
Managing
diabetes during
Ramadan can be
challenging1
1. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6
• 1 in 8 Muslim patients with
type 2 diabetes continue to
fast during Ramadan1
THE MAJORITY OF MUSLIM
PATIENTS WITH TYPE 2 DIABETES
WILL FAST DURING RAMADAN1
1. Salti I et al. Diabetes Care 2004;27:2306–2311.
of patients fasted
for
at least 15 days in
the Epidemiology
of Diabetes and
Ramadan
(EPIDIAR) study1
78.7%
Over the coming decade, the number of fasting
hours will progressively increase in the northern
hemisphere as Ramadan falls in the summer months.
Fasting increases the risk of hypoglycaemia
and hyperglycaemia as it can cause profound
changes in:1,2
DIETARY HABITS
LIFESTYLE
SLEEP PATTERNS
Despite this, only one third of patients adjust their
insulin
FASTING DURING RAMADAN
present a challenge in Muslim patients with
TYPE 2 DIABETES1
1. Salti I et al. Diabetes Care 2004;27:2306–2311. 2. Al-Arouj M et al. Diabetes Care 2005;28(9):2305–2311.
The Working Group for Insulin Therapy in Ramadan
developed practical advice for patients on low-ratio
premix insulin1
Guidance recommends preparation 2–3 months before
Ramadan to include:1
PREPARATION is KEY for management
of DIABETES during RAMADAN1
1. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6):794–799.
In line with current ADA
guidance to include
clinical assessment and
experience from previous
Ramadan
Pre-Ramadan
individualised
assessment
To include advice on
frequency of blood
glucose monitoring, diet,
physical activity and
when to break the fast
Structured education
To assess individual
response to fasting and
insulin needs
Trial fasting
for 3 days
• The Working Group for Insulin Therapy in Ramadan
recommends:1
• The management plan during Ramadan should be
individualised
• Glycaemic control needs to be ascertained
• Dosage will depend on meal size and composition, post-
meal fasting
period and individual blood glucose targets
• Appropriate treatment adjustments are necessary to avoid
both hypoglycaemia and hyperglycaemia.
It is simple to adjust NovoMixÂŽ 30, during
Ramadan to help minimise the risk of hypoglycaemia
or hyperglycaemia1
Patients FASTING during RAMADAN can be
managed with NovoMixÂŽ 301
1. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6):794–799.
1. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6):794–799.
It is simple to adjust NovoMixÂŽ 30
for altered mealtimes during Ramadan1
1. Adapted from Hassanein M et al. Indian J Endocrin Metab 2014;18(6):794–799.
DOSE BEFORE RAMADAN
PRE-IFTAR
(SUNSET
MEAL)
PRE-SUHUR
(DAWN
MEAL)
30/70 premix insulin
(e.g. NovoMixÂŽ 30) once
daily*
Same dose
as pre-
Ramadan
30/70 premix insulin
(e.g. NovoMixÂŽ 30) twice
daily**
Usual
morning
dose
Half usual
evening
dose
30/70 premix insulin
(e.g. NovoMixÂŽ 30) three
times daily†
Usual
morning
dose
Half usual
evening
dose
Patients receiving
human premix insulin
should be switched to
an analogue human
premix insulin:1
■ If immediate
injection before
meal is preferred1
■ If frequent
hypoglycaemia or
marked post-
prandial blood
glucose
excursions1
It is important for patients to
monitor blood glucose multiple times each day
during RAMADAN1
High risk
group (poor
control, high risk of
hypos)
Low risk
group (adequate
control, low risk of
hypoglycaemia)
Pre-Suhur Pre-Suhur
2 hours post-
Suhur
-
Midday Midday
Pre-Iftar Pre-Iftar
2 hours post-
Iftar
-
If symptoms of
hypoglycaemia
appear
If symptoms of
hypoglycaemia
appear
Reassure Patients That Blood
Glucose Testing Does Not Qualify
As Breaking The Fast1
The Frequency Of Monitoring Is
Dependent On Glycaemic Control
Level And Hypoglycaemia Risk1
Insulin Dose Titration And
Dosage Adjustment Should Be
Based On Pre-meal Blood Glucose
Levels1
It is simple to titrate
NovoMixÂŽ 30
, during Ramadan1
* Pre-Iftar dose to be adjusted based on pre-Suhur blood glucose and pre-Suhur dose to be adjusted based on pre-Iftar blood glucose levels
1. Adapted from Hassanein M et al. Indian J Endocrin Metab 2014;18(6):794–799.
Fasting/Pre-Iftar/Pre-Suhur
blood glucose level
30/70 premix insulin
dose adjustment
mmol/L mg/dL Units*
< 3.9 < 70
Break the fast
and down titrate
< 5.0 < 90 -2
5.0–7.0 90–126 0
> 7.0 > 126 +2
> 16.7 > 300
Break the fast and
increase dose by 4
units and check
ketones
It is advisable to
titrate
the low-ratio
premix insulin dose
every 3 days.1
A minimum of 2
readings on 2
consecutive days is
required to titrate
the dose.1
Fasting must be
broken if
hypoglycaemia
occurs.1
NovoMixÂŽ 30 offers
flexibility in dosing which may be important
during Ramadan*1,2
Relativeactionofinsulin
Physiological insulin profileTime
* HUMAN PREMIX INSULIN 30/70
1. NOVOMIXÂŽ 30 SUMMARY OF PRODUCT CHARACTERISTICS. 2. HASSANEIN M ET AL.
INDIAN J ENDOCRIN METAB 2014;18(6):794–799.
Human premix insulin*
should be administered at least 30 minutes before a meal1
Relativeactionofinsulin
Physiological insulin profile
Human premix insulin 30/70
30 minutes before a meal1
Time
30minutes
* Human premix insulin 30/70
1. Garber AJ et al. Diabetes Obes Metab 2007;9:630–639.
During Ramadan, this
means after a long
day fasting they will
need to wait an extra
30 minutes before
they can eat
Patients can take
NovoMixÂŽ 30 immediately BEFORE OR JUST AFTER
an important benefit during Ramadan
Relativeactionofinsulin
Physiological insulin profile
Human premix insulin 30/70
30 minutes before a meal3
NovoMixÂŽ 30
Immediately before a meal4
Time
30minutes
Higher maximum concentration
More effective PPG control1
Shorter acting
Reduces risk of hypoglycaemia2
Faster start action
Flexible mealtime injection – no
need to wait 30 minutes before
eating3,4
* Human premix insulin 30/70
1. Hermansen K et al. Diabetes Care 2002;25:883–888.
2. Davidson JH et al. Clin Ther 2009;31:1641–1651
3. Garber AJ et al. Diabetes Obes Metab 2007;9:630–639.
4. NovoMixÂŽ 30 Summary of Product Characteristics.
Hypoglycaemic
Episodes Are
More Common
During Ramadan
7.5x greater risk of severe hypoglycaemia during
Ramadan*1
Severe HYPOGLYCAEMIC episodes ;
were more frequent in patients who changed their OAD
dose, insulin dose or level of physical activity1
HYPOGLYCAEMIA
is the most common reason for breaking fast during
Ramadan2
HYPOGLYCAEMIA has a negative impact on patients’
quality of life and psychological wellbeing3
Fasting during Ramadan increases the risk of
HYPOGLYCAEMIC episodes1
*Defined as hospitalisation due to hypoglycaemia
1. Salti I et al. Diabetes Care 2004;27:2306–2311. 2. Elmehdawi RR et al. Libyan J Med
2010;5:5036 - DOI: 10.3402/ljm.v5i0.5036. 3. Davis RE et al. Curr Med Res Opin
2005;21(9):1477–1483.
Significantly fewer MAJOR HYPOGLYCAEMIC events
with
NovoMixÂŽ 30 human premix insulin*1
*Human premix insulin 30/70 **Vs human premix insulin, Odds ratio (95% CI): 0.45 (0.22–0.93),
p<0.05
1. Adapted from Davidson JA et al. Clin Ther 2009;31:1641–1651.
Trial
038
1234
1353
1394
1466
3002
Overall
Odds ratio (95% CI)
0.50 (0.12–1.98)
0.34 (0.01–8.28)
0.57 (0.16–2.00)
0.53 (0.03–8.63)
0.31 (0.06–1.54)
0.25 (0.01–6.62)
0.45 (0.22–0.93)
p
0.32
0.50
0.38
0.66
0.15
0.41
<0.05
Favours
NovoMixÂŽ 30
Favours human
premix insulin
0.01 0.1 1 10 100
Test of heterogeneity: I2 = 0%
Meta-analysis of major hypoglycaemia in
type 2 diabetes patients1
reduction in
likelihood of major
hypoglycaemia1**
reduction in
likelihood of
nocturnal
hypoglycaemia1**
Significantly fewer NOCTURNAL HYPOGLYCAEMIC
events with
NovoMixÂŽ 30 vs human premix insulin*1
*Human premix insulin 30/70 **Vs human premix insulin,
Rate ratio (95% CI): 0.50 (0.38–0.67), p<0.01
1. Adapted from Davidson JA et al. Clin Ther 2009;31:1641–1651.
Trial
038
1088
1234
1353
1394
1466
1536
3002
3006
Overall
Rate ratio (95% CI)
0.57 (0.20–1.58)
0.89 (0.25–3.16)
0.44 (0.22–0.89)
1.03 (0.42–2.53)
1.03 (0.38–2.76)
0.33 (0.21–0.51)
0.44 (0.11–1.47)
1.05 (0.11–10.09)
2.43 (0.31–18.90)
0.50 (0.38–0.67)
p
0.28
0.86
0.02
0.95
0.96
0.01
0.17
0.97
0.39
<0.01
Favours
NovoMixÂŽ 30
Favours human
premix insulin
0.1 0.2 1 10 20
Test of heterogeneity: I2 = 32%
Meta-analysis of nocturnal hypoglycaemia in
type 2 diabetes patients1
A1chieveÂŽ:
less hypoglycaemia after upgrading to
NovoMixÂŽ 30 from human premix insulin*1
*Human premix insulin 30/70
1. Adapted from El Naggar NK et al. Diabetes Res Clin Pract 2012;98:408–413.
0.69 0.03
5.31
2.04
Major
Eventsperpatient-year 10
6
4
2
0
8
Minor
Baseline on human premix
insulin*
After 6 months on NovoMixÂŽ 30
A Well-documented Tolerability Profile1–
8
2002–2014
NovoMixÂŽ 30
has been
studied in at
least 50 RCTs*
2007–2010
PRESENT™
observational
study1–3
>22,000
patients
2008–2012
IMPROVE™
observational
study4–6
>51,000
patients
2010–2012
A1chieveÂŽ
observational
study7,8
>66,000
patients
In 10 Middle
East Countries
*PubMed search on 2014.07.24 using term ‘biphasic insulin aspart’ and the limit ‘randomised controlled trial’
1. Adapted from Sharma SK et al. Curr Med Res Opin 2008;24:645–652. 2. Almustafa M et al. Diabetes Res Clin
Pract 2008;81(Suppl. 1):S10–15. 3. Güler S et al. Arch Drug Inf 2009;
2:23–33. 4. Valensi P et al. Int J Clin Pract 2009;63:522–531. 5. Yang W et al. Curr Med Res Opin 2009;25:2643–
2654. 6. Gumprecht J et al. Int J Clin Pract 2009;63:966–972.
7. Home P et al. Diabetes Res Clin Pract 2011;94:352–363. 8. El Naggar NK et al. Diabetes Res Clin Pract
2012;93:408–413.
of clinical
experience*1–8
12 YEARS
NovoMixÂŽ 30
tolerability profile
demonstrated over
THE RISK OF
HYPERGLYCAEMIA
IS INCREASED
DURING RAMADAN
5x greater risk of severe
hyperglycaemia/ketoacidosis during Ramadan1
Excessive reductions in insulin doses to avoid
hypoglycaemia or changes to diet and mealtimes
can lead to post-prandial hyperglycaemic episodes2
Post-prandial hyperglycaemia is an independent
risk factor for cardiovascular and macrovascular
disease*3
Fasting during Ramadan
increases
the RISK of HYPERGLYCAEMIA1
*There is no available data linking repeated short-term episodes of hyperglycaemia during Ramadan
to long-term complications
1. Salti I et al. Diabetes Care 2004;27:2306–2311. 2. Hassanein M et al. Indian J Endocrinol Metab
2014;18(6):794–799. 3. 2011 Guideline for Management of PostMeal Glucose in Diabetes. Available at:
www.idf.org/2011-guidelinemanagement-postmeal-glucose-diabetes (accessed March 2015).
Every 1% reduction in HbA1c
can reduce long-term
DIABETES COMPLICATIONS1
*p<0.0001
1. Adapted from Stratton IM et al. BMJ 2000;321:405–412.
37%
21%
14%
Microvascular
complications*
Deaths related
to diabetes*
Myocardial
infarction*
Targeting both PPG and FPG is an important strategy
for achieving optimal glycaemic control1
1. 2011 Guideline for Management of PostMeal Glucose in Diabetes.
Available at: www.idf.org/2011-guideline-management-postmeal-glucose-diabetes (accessed
March 2015). 2. Adapted from Monnier L et al. Diabetes Care 2003;26:881−885.
HbA1c
PPG FPG
Glucose
triad2
A1chieveÂŽ:
NovoMixÂŽ 30 reduced PPG and FPG
in patients switching from glargine
*82.6% of patients were on NovoMix® 30 bid by study end (24 weeks) **p<0.001 †Post-
lunch and post-dinner also significant (81.1 and 77.5 mg/dL reduction, respectively)
1. Adapted from Haddad J et al. Diabetes Ther 2013;4:309−319.
187.4
135.1
Baseline
Week 24
270.3
187.4
Pre-breakfast
FPG
Bloodglucose(mg/dL)
300
150
100
50
0
200
250
Post-breakfast
PPG**
Lower
PPG and FPG from
baseline at week
24 after switching
from glargine to
NovoMixÂŽ 301
A1chieveÂŽ:
NovoMixÂŽ 30 reduced PPG and FPG
in patients switching from a glargine-based basal–bolus
regimen1
*p<0.001 **Post-lunch and post-dinner also significant (73.8 and 59.4 mg/dL reduction, respectively)
1. Adapted from Dieuzeide G et al. Prim Care Diabetes 2014;8(2):111−117.
210.8
135.1
Baseline
Week 24
259.5
165.8
Pre-breakfast
FPG
Bloodglucose(mg/dL)
300
150
100
50
0
200
250
Post-breakfast
PPG**
PPG and FPG from baseline
at week 24 after switching
to NovoMixÂŽ 30 from a
glargine-based basal-bolus
regimen1
Significantly
lower
PRESENTTM:
PPG levels significantly improved after upgrading to
NovoMixÂŽ 30 human premix insulin1
*Human premix insulin 30/70
1. Adapted from Shestakova M et al. Curr Med Res Opin 2007;23(12):3209–3214.
Baseline on human premix insulin*
After 6 months on NovoMixÂŽ 30
275.5
188.3
Bloodglucose(mg/dL)
300
150
100
50
0
200
250
PPG
IMPROVETM:
PPG levels significantly improved after upgrading to
NovoMixÂŽ 30 human premix insulin1
*p<0.0001 **Human premix insulin 30/70
1. Adapted from Shah S et al. Int J Clin Pract 2009;63:574–582.
268.5
169.4
266.7
173
207.2
149.6
Baseline on human premix
insulin**
After 6 months on NovoMixÂŽ 30
PPG breakfast
Bloodglucose(mg/dL)
300
150
100
50
0
200
PPG lunch PPG dinner
250
A1chieveÂŽ:
PPG levels significantly improved at each meal after upgrading
to
NovoMixÂŽ 30 from human premix insulin1
*p<0.001 **Human premix insulin 30/70
1. Adapted from El Naggar NK et al. Diabetes Res Clin Pract 2012;98:408–413.
255.9
178.4
239.6
158.5
221.6
156.8
Baseline on human premix insulin**
After 6 months on NovoMixÂŽ 30
Post-breakfast
Bloodglucose(mg/dL)
300
150
100
50
0
200
Post-lunch Post-dinner
250
COMPLEX
REGIMEN
REDUCE
ADHERENCE
MEDICATION
■During Ramadan,
the majority of
patients using a
basal-bolus
regimen will
require
3 daily injections5
COMPLEX REGIMEN
can reduce adherence,1–4
which may lead to suboptimal treatment
1. Rubin RR. Am J Med 2005;118(5A):27S−34S. 2. Vijan S et al. J Gen Intern Med 2005;20:479−482. 3.
Dieuzeide G et al. Prim Care Diabetes 2014;8(2):111–117. 4. Donnelly LA et al. Q J Med
2007;100:345−350. 5. Al-Arouj M et al. Diabetes Care 2010;33(8):1895–1902.
During Ramadan, the
majority of patients will
receive 2 daily injections
of a premix insulin, with
meals after sunset and
before dawn2
Premixed insulin may
be more convenient than
adding in bolus mealtime
injections, as part of a
basal–bolus regimen1
Fewer injections are required with
NovoMixÂŽ 30
Than A Basal–Bolus Regimen1
1. Inzucchi SE et al. Diabetes Care 2012;35(6):1364–1379. 2. Hassanein M et al. Indian J
Endocrinol Metab 2014;18(6):794–799.
IN SUMMARY
DIABETICS IN
RAMADAN
■Fasting during Ramadan increases the risk of
hypoglycaemia
■NovoMix® 30 shows a lower risk of major and
nocturnal hypoglycaemia* vs human premix insulin
■Fasting during Ramadan increases the risk of
hyperglycaemia
■Post-prandial hyperglycaemia is an independent
risk factor for cardiovascular and macrovascular
disease
■NovoMix® 30 od provides more effective PPG
control vs glargine once daily.
HYPOGLYCEMIA
HYPERGLYCEMIA
Managing DIABETES During RAMADAN
Can Be Challenging1
The majority of Muslim patients with type 2 diabetes fast
during Ramadan1
Appropriate treatment adjustments, including insulin
regimen, are necessary to avoid hypoglycaemia and
hyperglycaemia2
NovoMixÂŽ 30
adds confidence to control
It is simple to adjust NovoMixŽ 30, during Ramadan to
help minimise the risk of hypoglycaemia or
hyperglycaemia
Flexible mealtime dosing – patients can eat immediately
after injecting NovoMixÂŽ 30
More effective PPG control and lower risk of major and
nocturnal hypoglycaemia* vs human premix insulin
IN SUMMARY
Me
At
work
Me
At home
I need urgent
Ophthalmology consultation
THANK YOU
DR./ ADEL EL NAGGAR

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Dr.adel elnaggar 5 6-2015 pre ramadan management with novomix

  • 1.
  • 2. DR./ADEL ELNAGGAR Endocrinologist Ain Shams University, EGYPT. Postgraduate Diabetes, UK. Dr.Erfan & Bagedo Hospital
  • 3.
  • 5. DIABETES SPOT LIGHTS RAMDAN & DIABETES NOVEL PREMIX INSULIN TOPICS
  • 6.
  • 7.
  • 8. Risk Factors • Obesity • Race • History of CVD • HTN • Physical inactivity • Familial history • Polycystic Ovary Syndrome • Gestational Diabetes ? ? ? ? ? ? ?
  • 9.
  • 10.
  • 11. (LACK OF DIABETES PYRAMID STRATEGIES): BASE: Early detection; diagnosis & prevention Programs (Health Education). BODY: Proper scientific socio-economic Management (Qualified Health Care Providers). TOP: Delay or prevent Diabetic Complications (Reduce Morbidity & Mortality).
  • 12.
  • 13.
  • 15. PANCREAS HORMONES: INSULIN BY BETA CELLS GLUCAGON BY ALPHA CELLS Review of Anatomy and Physiology
  • 16. • Pancreas secretes 40-50 units of insulin daily in two steps: • Secreted at low levels during fasting ( basal insulin secretion) • Increased levels after eating (prandial) • An early burst of insulin occurs within 10 minutes of eating • Then proceeds with increasing release as long as hyperglycemia is present
  • 17. Insulin • Insulin allows glucose to move into cells to make energy • Inhibits glucagon activity
  • 18. Action of Insulin on Carbohydrate, Protein and Fat Metabolism •Carbohydrate • Facilitates the transport of glucose into muscle and adipose cells • Facilitates the conversion of glucose to glycogen for storage in the liver and muscle. • Decreases the breakdown and release of glucose from glycogen by the liver
  • 19. Action of Insulin on Carbohydrate, Protein and Fat Metabolism •Fat • Stimulates lipogenesis- the transport of triglycerides to adipose tissue • Inhibits lipolysis – prevents excessive production of ketones or ketoacidosis
  • 20. Action of Insulin on Carbohydrate, Protein and Fat Metabolism •Protein • Stimulates protein synthesis • Inhibits protein breakdown; diminishes gluconeogenesis
  • 21. What goes wrong in diabetes? • Multitude of mechanisms • Insulin • Regulation • Secretion • Uptake or breakdown • Beta cells • damage
  • 22.
  • 23.
  • 24.
  • 25. Pre-Diabetes •Impaired fasting glucose (IFG) •FPG- 100-125mg/dL •Impaired glucose tolerance (IGT) •OGTT 140-199mg/dL •HbA1c 6-6.5%
  • 26.
  • 27. Insulin resistance metabolic syndrome adults obese Central obesity (waist circumference) IGT or IFG High lipid profile LDL-HDL/CHOLESTEROL/TRIGLYCERIDES HIGH BP more than 130/90
  • 28.
  • 29.
  • 30.
  • 31. MANAGEMENT OF DIABETES Life style modification Diet Exrcise Psychological support
  • 32.
  • 33.
  • 34. MANAGEMENT OF DIABETES METFORMIN DPP4 PIOGLTAZONES GLP1 ANALOUGES SGLT2 INHIBITORS SUs INSULINs PANCREATIC TRANSPLANTION STEM CELLS METABOLIC SURGERIES
  • 35.
  • 37.
  • 38.
  • 39.
  • 40. • Islamic holy month where fasting is compulsory for all healthy Muslims • Absolute fast between sunrise and sunset. • Muslims fast from: • Food • Liquids • Medication Ramadan
  • 41. • Children • Elderly • Sick • Pregnant or nursing mothers • Menstruating women • People with chronic illness (e.g. DM, CKD, CVD)
  • 42. • Which Patients with DIABETES are Exempt from Fasting during RAMADAN??? Patients With High Risk Of Complications. Many Muslims with diabetes insist on fasting during Ramadan. This creates a medical challenges for both patients and physicians. Al-Arouj et al. Diabetes Care 2005;28:2305–11 Salti et al. Diabetes Care 2004;27:2306–11
  • 43.
  • 44. CNS, central nervous system; GI, gastrointestinal; T2DM, type 2 diabetes mellitus Cernea S & Raz I. Diabetes Care 2011;34(suppl 2):S264–S271 Adipocyte CNS Incretin deficiency GI tract Altered fat metabolism INSULIN RESISTANCE INADEQUATE INSULIN SECRETION ↑ HEPATIC GLUCOSE PRODUCTION ↑ BLOOD GLUCOSE Hyperglucagonaemia ↑ hepatic sensitivity to glucagon  cells Îą cells Skeletal Muscle Pancreas Muscle Kidney Enhanced glucose reabsorption Pathophysiology Of Type 2 DIABETES
  • 45. body glucose, which is stored in the liver and muscles, is the body’s main source of energy. Early In The Fast ; this store of glucose is used up first to provide energy. Later In The Fast ; once the stores of glucose run out, fat becomes the next store source of energy for the body.Mahroof,Ramadan Health Guide : a guide to healthy fasting ,Department of Health ,Sept,2007 Physiological Changes That Occur During A Fast In The Normal State During A Fast
  • 46.
  • 47.
  • 48.  Type 1 Diabetes  Severe Hypoglycaemia Or Ketoacidosis Within Last Three Months Prior To Ramadan  Recurrent Hypoglycaemia  Sustained Poor Glycaemic Control  Acute Illness  Pregnancy  Type 2 diabetes  Moderate hyperglycaemia  Renal insufficiency  Advanced macro vascular complications  Living alone and treated with sulphonylurea or insulin  Comorbid conditions that present additional risk factors Al-Arouj et al. Diabetes Care 2005;28:2305–11 Patients at HIGH RISK of developing COMPLICATIONS during Ramadan VERY HIGH RISK HIGH RISK
  • 49.
  • 50.
  • 51. Salti et al. Diabetes Care 2004;27:2306–11 • AIM: to study diabetes during Ramadan and investigate the effects of fasting • Population: 12,243 Muslim patients with diabetes in 13 countries • Demographics: Demographics Type 1 diabetes Type 2 diabetes Number 1070 11,173 Male/Female (%) 50/50 49/51 Age (years)* 31 (12.7) 54 (11.0) Duration of diabetes (years)* 10 (7.6) 7.6 (5.8) *Data are mean (SD) Percentage of patients reported fasting at least 15 days: type 1 – 42.8% type 2 – 78.7% Epidemiology of DIABETES and Ramadan (EPI-DIA-R) study
  • 52.
  • 53.
  • 54. Proportionofpatients(%) Type 1 diabetes (n=899) Type 2 diabetes (n=9775) Body weight changes during Ramadan Adapted from Salti et al. Diabetes Care 2004;27:2306–11 EPIDIAR study - Results
  • 55. Proportionofpatients(%) Changes in medication during Ramadan Type 1 diabetes Type 2 diabetes Insulin dose (n=980) OAD dose (n=94) Insulin dose (n=1831) OAD dose (n=9476) Adapted from Salti et al. Diabetes Care 2004;27:2306–11 EPIDIAR study - Results OAD, oral anti-diabetic drug
  • 56. Numberofeventspermonth Type 1 diabetes Type 2 diabetes Severe hyperglycaemia with or without ketoacidosis in patients who fasted ≥15 days 0.00 0.04 0.08 0.12 0.16 0.20 Before Ramadan During Ramadan p=0.0015 Adapted from Salti et al. Diabetes Care 2004;27:2306–11 p=0.67 EPIDIAR study - Results
  • 57. Type 1 diabetes Type 2 diabetes Before Ramadan During Ramadan p-value Before Ramadan During Ramadan p-value Overall population 0.03 0.14 0.0174 0.004 0.03 <0.0001 Patients who fasted ≥15 days 0.02 0.12 0.9896 0.003 0.02 0.0015 Number of severe hypoglycaemic events during Ramadan (number per month) Data (except p values) are mean Adapted from Salti et al. Diabetes Care 2004;27:2306–11 4.5 Folds 7.5 Folds 6 Folds 6.5 Folds EPIDIAR study - Results
  • 58. Al-Arouj et al. Diabetes Care 2005;28:2305–11 E Hui et al. BMJ 2010;340:1407–11 RECOMMENDATIONS
  • 59. • Individualisation • Patient specific recommendations • Frequent monitoring of glycaemia • Crucial for patients with type 1 diabetes and patients with type 2 diabetes who require insulin treatment • This will not break the fast • Nutrition • Healthy and balanced diet • Ingesting large amount of foods rich in carbohydrate and fat should be avoided • Exercise • Maintain normal levels of physical activity • Breaking the fast • Blood glucose <3.3 mmol/L or >16.7 mmol/L Al-Arouj et al. Diabetes Care 2005;28:2305–11; GENERAL CONSIDERATION & RULES for the management of DIABETES during RAMADAN
  • 60. DIET-CONTROLLED PATIENTS • Risk associated with fasting is low in patients who are adequately controlled with diet alone • Potential risk of postprandial hyperglycaemia if patients overindulge in eating • Daily exercise programme may need to be modified to avoid hypoglycaemia • Fluid restrictions and dehydration may increase the risk of thrombosis Al-Arouj et al. Diabetes Care 2005;28:2305–11 Management of patients with TYPE 2 DIABETES during RAMADAN
  • 61. Patients treated with oral agents • METFORMIN • Minimal possibility of hypoglycaemia • Timing of doses should be modified • ACARBOSE • Continue with the prescribed doses • taken only with meals • GLITAZONES • Low risk of hypoglycaemia • No change in dose required • SHORT-ACTING INSULIN SECRETAGOGUES • Short duration of action • Twice-daily dosing pre-meals • SULPHONYLUREAS • Increased risk of hypoglycaemia Suitable for use during Ramadan Use with caution during Ramadan Al-Arouj et al. Diabetes Care 2005;28:2305–11 & E Hui et al. BMJ 2010;340:1407–11 Management of patients with TYPE 2 DIABETES during RAMADAN
  • 62. He Used To Worry About Managing His Diabetes During Ramadan
  • 63. Managing diabetes during Ramadan can be challenging1 The majority of Muslim patients with type 2 diabetes fast during Ramadan1 proper treatment adjustments, including INSULIN REGIMEN, are necessary to avoid HYPOGLYCAEMIA and HYPERGLYCAEMIA2 1. Salti I et al. Diabetes Care 2004;27:2306–2311. 2. 2. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6):794–799.
  • 64.
  • 65.
  • 66. NovoMixÂŽ 30 adds confidence to control It Is Simple To Adjust NovomixÂŽ 30, During Ramadan To Help Minimise The RISK Of Hypoglycaemia Or Hyperglycaemia1 Flexible Mealtime Dosing – Patients Can Eat Immediately After Injecting NovomixÂŽ 302 More Effective PPG Control And Lower Risk Of Major And Nocturnal Hypoglycaemia* Vs Human Premix Insulin3,4 1. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6):794–799. 2. NovoMixÂŽ 30 Summary of Product Characteristics. 3. Hermansen K et al. Diabetes Care 2002;25:883–888. 4. Davidson JA et al. Clin Ther 2009;31:1641–1651.
  • 67. Managing diabetes during Ramadan can be challenging1 1. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6
  • 68. • 1 in 8 Muslim patients with type 2 diabetes continue to fast during Ramadan1 THE MAJORITY OF MUSLIM PATIENTS WITH TYPE 2 DIABETES WILL FAST DURING RAMADAN1 1. Salti I et al. Diabetes Care 2004;27:2306–2311. of patients fasted for at least 15 days in the Epidemiology of Diabetes and Ramadan (EPIDIAR) study1 78.7%
  • 69. Over the coming decade, the number of fasting hours will progressively increase in the northern hemisphere as Ramadan falls in the summer months. Fasting increases the risk of hypoglycaemia and hyperglycaemia as it can cause profound changes in:1,2 DIETARY HABITS LIFESTYLE SLEEP PATTERNS Despite this, only one third of patients adjust their insulin FASTING DURING RAMADAN present a challenge in Muslim patients with TYPE 2 DIABETES1 1. Salti I et al. Diabetes Care 2004;27:2306–2311. 2. Al-Arouj M et al. Diabetes Care 2005;28(9):2305–2311.
  • 70. The Working Group for Insulin Therapy in Ramadan developed practical advice for patients on low-ratio premix insulin1 Guidance recommends preparation 2–3 months before Ramadan to include:1 PREPARATION is KEY for management of DIABETES during RAMADAN1 1. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6):794–799. In line with current ADA guidance to include clinical assessment and experience from previous Ramadan Pre-Ramadan individualised assessment To include advice on frequency of blood glucose monitoring, diet, physical activity and when to break the fast Structured education To assess individual response to fasting and insulin needs Trial fasting for 3 days
  • 71. • The Working Group for Insulin Therapy in Ramadan recommends:1 • The management plan during Ramadan should be individualised • Glycaemic control needs to be ascertained • Dosage will depend on meal size and composition, post- meal fasting period and individual blood glucose targets • Appropriate treatment adjustments are necessary to avoid both hypoglycaemia and hyperglycaemia. It is simple to adjust NovoMixÂŽ 30, during Ramadan to help minimise the risk of hypoglycaemia or hyperglycaemia1 Patients FASTING during RAMADAN can be managed with NovoMixÂŽ 301 1. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6):794–799.
  • 72. 1. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6):794–799.
  • 73. It is simple to adjust NovoMixÂŽ 30 for altered mealtimes during Ramadan1 1. Adapted from Hassanein M et al. Indian J Endocrin Metab 2014;18(6):794–799. DOSE BEFORE RAMADAN PRE-IFTAR (SUNSET MEAL) PRE-SUHUR (DAWN MEAL) 30/70 premix insulin (e.g. NovoMixÂŽ 30) once daily* Same dose as pre- Ramadan 30/70 premix insulin (e.g. NovoMixÂŽ 30) twice daily** Usual morning dose Half usual evening dose 30/70 premix insulin (e.g. NovoMixÂŽ 30) three times daily† Usual morning dose Half usual evening dose Patients receiving human premix insulin should be switched to an analogue human premix insulin:1 ■ If immediate injection before meal is preferred1 ■ If frequent hypoglycaemia or marked post- prandial blood glucose excursions1
  • 74. It is important for patients to monitor blood glucose multiple times each day during RAMADAN1 High risk group (poor control, high risk of hypos) Low risk group (adequate control, low risk of hypoglycaemia) Pre-Suhur Pre-Suhur 2 hours post- Suhur - Midday Midday Pre-Iftar Pre-Iftar 2 hours post- Iftar - If symptoms of hypoglycaemia appear If symptoms of hypoglycaemia appear Reassure Patients That Blood Glucose Testing Does Not Qualify As Breaking The Fast1 The Frequency Of Monitoring Is Dependent On Glycaemic Control Level And Hypoglycaemia Risk1 Insulin Dose Titration And Dosage Adjustment Should Be Based On Pre-meal Blood Glucose Levels1
  • 75. It is simple to titrate NovoMixÂŽ 30 , during Ramadan1 * Pre-Iftar dose to be adjusted based on pre-Suhur blood glucose and pre-Suhur dose to be adjusted based on pre-Iftar blood glucose levels 1. Adapted from Hassanein M et al. Indian J Endocrin Metab 2014;18(6):794–799. Fasting/Pre-Iftar/Pre-Suhur blood glucose level 30/70 premix insulin dose adjustment mmol/L mg/dL Units* < 3.9 < 70 Break the fast and down titrate < 5.0 < 90 -2 5.0–7.0 90–126 0 > 7.0 > 126 +2 > 16.7 > 300 Break the fast and increase dose by 4 units and check ketones It is advisable to titrate the low-ratio premix insulin dose every 3 days.1 A minimum of 2 readings on 2 consecutive days is required to titrate the dose.1 Fasting must be broken if hypoglycaemia occurs.1
  • 76. NovoMixÂŽ 30 offers flexibility in dosing which may be important during Ramadan*1,2 Relativeactionofinsulin Physiological insulin profileTime * HUMAN PREMIX INSULIN 30/70 1. NOVOMIXÂŽ 30 SUMMARY OF PRODUCT CHARACTERISTICS. 2. HASSANEIN M ET AL. INDIAN J ENDOCRIN METAB 2014;18(6):794–799.
  • 77. Human premix insulin* should be administered at least 30 minutes before a meal1 Relativeactionofinsulin Physiological insulin profile Human premix insulin 30/70 30 minutes before a meal1 Time 30minutes * Human premix insulin 30/70 1. Garber AJ et al. Diabetes Obes Metab 2007;9:630–639. During Ramadan, this means after a long day fasting they will need to wait an extra 30 minutes before they can eat
  • 78. Patients can take NovoMixÂŽ 30 immediately BEFORE OR JUST AFTER an important benefit during Ramadan Relativeactionofinsulin Physiological insulin profile Human premix insulin 30/70 30 minutes before a meal3 NovoMixÂŽ 30 Immediately before a meal4 Time 30minutes Higher maximum concentration More effective PPG control1 Shorter acting Reduces risk of hypoglycaemia2 Faster start action Flexible mealtime injection – no need to wait 30 minutes before eating3,4 * Human premix insulin 30/70 1. Hermansen K et al. Diabetes Care 2002;25:883–888. 2. Davidson JH et al. Clin Ther 2009;31:1641–1651 3. Garber AJ et al. Diabetes Obes Metab 2007;9:630–639. 4. NovoMixÂŽ 30 Summary of Product Characteristics.
  • 80. 7.5x greater risk of severe hypoglycaemia during Ramadan*1 Severe HYPOGLYCAEMIC episodes ; were more frequent in patients who changed their OAD dose, insulin dose or level of physical activity1 HYPOGLYCAEMIA is the most common reason for breaking fast during Ramadan2 HYPOGLYCAEMIA has a negative impact on patients’ quality of life and psychological wellbeing3 Fasting during Ramadan increases the risk of HYPOGLYCAEMIC episodes1 *Defined as hospitalisation due to hypoglycaemia 1. Salti I et al. Diabetes Care 2004;27:2306–2311. 2. Elmehdawi RR et al. Libyan J Med 2010;5:5036 - DOI: 10.3402/ljm.v5i0.5036. 3. Davis RE et al. Curr Med Res Opin 2005;21(9):1477–1483.
  • 81. Significantly fewer MAJOR HYPOGLYCAEMIC events with NovoMixÂŽ 30 human premix insulin*1 *Human premix insulin 30/70 **Vs human premix insulin, Odds ratio (95% CI): 0.45 (0.22–0.93), p<0.05 1. Adapted from Davidson JA et al. Clin Ther 2009;31:1641–1651. Trial 038 1234 1353 1394 1466 3002 Overall Odds ratio (95% CI) 0.50 (0.12–1.98) 0.34 (0.01–8.28) 0.57 (0.16–2.00) 0.53 (0.03–8.63) 0.31 (0.06–1.54) 0.25 (0.01–6.62) 0.45 (0.22–0.93) p 0.32 0.50 0.38 0.66 0.15 0.41 <0.05 Favours NovoMixÂŽ 30 Favours human premix insulin 0.01 0.1 1 10 100 Test of heterogeneity: I2 = 0% Meta-analysis of major hypoglycaemia in type 2 diabetes patients1 reduction in likelihood of major hypoglycaemia1**
  • 82. reduction in likelihood of nocturnal hypoglycaemia1** Significantly fewer NOCTURNAL HYPOGLYCAEMIC events with NovoMixÂŽ 30 vs human premix insulin*1 *Human premix insulin 30/70 **Vs human premix insulin, Rate ratio (95% CI): 0.50 (0.38–0.67), p<0.01 1. Adapted from Davidson JA et al. Clin Ther 2009;31:1641–1651. Trial 038 1088 1234 1353 1394 1466 1536 3002 3006 Overall Rate ratio (95% CI) 0.57 (0.20–1.58) 0.89 (0.25–3.16) 0.44 (0.22–0.89) 1.03 (0.42–2.53) 1.03 (0.38–2.76) 0.33 (0.21–0.51) 0.44 (0.11–1.47) 1.05 (0.11–10.09) 2.43 (0.31–18.90) 0.50 (0.38–0.67) p 0.28 0.86 0.02 0.95 0.96 0.01 0.17 0.97 0.39 <0.01 Favours NovoMixÂŽ 30 Favours human premix insulin 0.1 0.2 1 10 20 Test of heterogeneity: I2 = 32% Meta-analysis of nocturnal hypoglycaemia in type 2 diabetes patients1
  • 83. A1chieveÂŽ: less hypoglycaemia after upgrading to NovoMixÂŽ 30 from human premix insulin*1 *Human premix insulin 30/70 1. Adapted from El Naggar NK et al. Diabetes Res Clin Pract 2012;98:408–413. 0.69 0.03 5.31 2.04 Major Eventsperpatient-year 10 6 4 2 0 8 Minor Baseline on human premix insulin* After 6 months on NovoMixÂŽ 30
  • 84. A Well-documented Tolerability Profile1– 8 2002–2014 NovoMixÂŽ 30 has been studied in at least 50 RCTs* 2007–2010 PRESENT™ observational study1–3 >22,000 patients 2008–2012 IMPROVE™ observational study4–6 >51,000 patients 2010–2012 A1chieveÂŽ observational study7,8 >66,000 patients In 10 Middle East Countries *PubMed search on 2014.07.24 using term ‘biphasic insulin aspart’ and the limit ‘randomised controlled trial’ 1. Adapted from Sharma SK et al. Curr Med Res Opin 2008;24:645–652. 2. Almustafa M et al. Diabetes Res Clin Pract 2008;81(Suppl. 1):S10–15. 3. GĂźler S et al. Arch Drug Inf 2009; 2:23–33. 4. Valensi P et al. Int J Clin Pract 2009;63:522–531. 5. Yang W et al. Curr Med Res Opin 2009;25:2643– 2654. 6. Gumprecht J et al. Int J Clin Pract 2009;63:966–972. 7. Home P et al. Diabetes Res Clin Pract 2011;94:352–363. 8. El Naggar NK et al. Diabetes Res Clin Pract 2012;93:408–413. of clinical experience*1–8 12 YEARS NovoMixÂŽ 30 tolerability profile demonstrated over
  • 85. THE RISK OF HYPERGLYCAEMIA IS INCREASED DURING RAMADAN
  • 86. 5x greater risk of severe hyperglycaemia/ketoacidosis during Ramadan1 Excessive reductions in insulin doses to avoid hypoglycaemia or changes to diet and mealtimes can lead to post-prandial hyperglycaemic episodes2 Post-prandial hyperglycaemia is an independent risk factor for cardiovascular and macrovascular disease*3 Fasting during Ramadan increases the RISK of HYPERGLYCAEMIA1 *There is no available data linking repeated short-term episodes of hyperglycaemia during Ramadan to long-term complications 1. Salti I et al. Diabetes Care 2004;27:2306–2311. 2. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6):794–799. 3. 2011 Guideline for Management of PostMeal Glucose in Diabetes. Available at: www.idf.org/2011-guidelinemanagement-postmeal-glucose-diabetes (accessed March 2015).
  • 87. Every 1% reduction in HbA1c can reduce long-term DIABETES COMPLICATIONS1 *p<0.0001 1. Adapted from Stratton IM et al. BMJ 2000;321:405–412. 37% 21% 14% Microvascular complications* Deaths related to diabetes* Myocardial infarction*
  • 88. Targeting both PPG and FPG is an important strategy for achieving optimal glycaemic control1 1. 2011 Guideline for Management of PostMeal Glucose in Diabetes. Available at: www.idf.org/2011-guideline-management-postmeal-glucose-diabetes (accessed March 2015). 2. Adapted from Monnier L et al. Diabetes Care 2003;26:881−885. HbA1c PPG FPG Glucose triad2
  • 89. A1chieveÂŽ: NovoMixÂŽ 30 reduced PPG and FPG in patients switching from glargine *82.6% of patients were on NovoMixÂŽ 30 bid by study end (24 weeks) **p<0.001 †Post- lunch and post-dinner also significant (81.1 and 77.5 mg/dL reduction, respectively) 1. Adapted from Haddad J et al. Diabetes Ther 2013;4:309−319. 187.4 135.1 Baseline Week 24 270.3 187.4 Pre-breakfast FPG Bloodglucose(mg/dL) 300 150 100 50 0 200 250 Post-breakfast PPG** Lower PPG and FPG from baseline at week 24 after switching from glargine to NovoMixÂŽ 301
  • 90. A1chieveÂŽ: NovoMixÂŽ 30 reduced PPG and FPG in patients switching from a glargine-based basal–bolus regimen1 *p<0.001 **Post-lunch and post-dinner also significant (73.8 and 59.4 mg/dL reduction, respectively) 1. Adapted from Dieuzeide G et al. Prim Care Diabetes 2014;8(2):111−117. 210.8 135.1 Baseline Week 24 259.5 165.8 Pre-breakfast FPG Bloodglucose(mg/dL) 300 150 100 50 0 200 250 Post-breakfast PPG** PPG and FPG from baseline at week 24 after switching to NovoMixÂŽ 30 from a glargine-based basal-bolus regimen1 Significantly lower
  • 91. PRESENTTM: PPG levels significantly improved after upgrading to NovoMixÂŽ 30 human premix insulin1 *Human premix insulin 30/70 1. Adapted from Shestakova M et al. Curr Med Res Opin 2007;23(12):3209–3214. Baseline on human premix insulin* After 6 months on NovoMixÂŽ 30 275.5 188.3 Bloodglucose(mg/dL) 300 150 100 50 0 200 250 PPG
  • 92. IMPROVETM: PPG levels significantly improved after upgrading to NovoMixÂŽ 30 human premix insulin1 *p<0.0001 **Human premix insulin 30/70 1. Adapted from Shah S et al. Int J Clin Pract 2009;63:574–582. 268.5 169.4 266.7 173 207.2 149.6 Baseline on human premix insulin** After 6 months on NovoMixÂŽ 30 PPG breakfast Bloodglucose(mg/dL) 300 150 100 50 0 200 PPG lunch PPG dinner 250
  • 93. A1chieveÂŽ: PPG levels significantly improved at each meal after upgrading to NovoMixÂŽ 30 from human premix insulin1 *p<0.001 **Human premix insulin 30/70 1. Adapted from El Naggar NK et al. Diabetes Res Clin Pract 2012;98:408–413. 255.9 178.4 239.6 158.5 221.6 156.8 Baseline on human premix insulin** After 6 months on NovoMixÂŽ 30 Post-breakfast Bloodglucose(mg/dL) 300 150 100 50 0 200 Post-lunch Post-dinner 250
  • 95. ■During Ramadan, the majority of patients using a basal-bolus regimen will require 3 daily injections5 COMPLEX REGIMEN can reduce adherence,1–4 which may lead to suboptimal treatment 1. Rubin RR. Am J Med 2005;118(5A):27S−34S. 2. Vijan S et al. J Gen Intern Med 2005;20:479−482. 3. Dieuzeide G et al. Prim Care Diabetes 2014;8(2):111–117. 4. Donnelly LA et al. Q J Med 2007;100:345−350. 5. Al-Arouj M et al. Diabetes Care 2010;33(8):1895–1902.
  • 96. During Ramadan, the majority of patients will receive 2 daily injections of a premix insulin, with meals after sunset and before dawn2 Premixed insulin may be more convenient than adding in bolus mealtime injections, as part of a basal–bolus regimen1 Fewer injections are required with NovoMixÂŽ 30 Than A Basal–Bolus Regimen1 1. Inzucchi SE et al. Diabetes Care 2012;35(6):1364–1379. 2. Hassanein M et al. Indian J Endocrinol Metab 2014;18(6):794–799.
  • 97. IN SUMMARY DIABETICS IN RAMADAN ■Fasting during Ramadan increases the risk of hypoglycaemia ■NovoMixÂŽ 30 shows a lower risk of major and nocturnal hypoglycaemia* vs human premix insulin ■Fasting during Ramadan increases the risk of hyperglycaemia ■Post-prandial hyperglycaemia is an independent risk factor for cardiovascular and macrovascular disease ■NovoMixÂŽ 30 od provides more effective PPG control vs glargine once daily. HYPOGLYCEMIA HYPERGLYCEMIA
  • 98. Managing DIABETES During RAMADAN Can Be Challenging1 The majority of Muslim patients with type 2 diabetes fast during Ramadan1 Appropriate treatment adjustments, including insulin regimen, are necessary to avoid hypoglycaemia and hyperglycaemia2 NovoMixÂŽ 30 adds confidence to control It is simple to adjust NovoMixÂŽ 30, during Ramadan to help minimise the risk of hypoglycaemia or hyperglycaemia Flexible mealtime dosing – patients can eat immediately after injecting NovoMixÂŽ 30 More effective PPG control and lower risk of major and nocturnal hypoglycaemia* vs human premix insulin IN SUMMARY
  • 102. THANK YOU DR./ ADEL EL NAGGAR