2. Hypoglycemia Among Type 2 Diabetics Fasting Ramadan Dr
Hypoglycemia Among Type 2 Diabetics Fasting Ramadan Dr. Khaled Tayeb

3. To Fast during the month of Ramadan-Prayer and supplication to God-Discipline to be observed during the month-Rights of property to be respected
(183) يَا أَيُّهَا الَّذِينَ آمَنُواْ كُتِبَ عَلَيْكُمُ الصِّيَامُ كَمَا كُتِبَ عَلَى الَّذِينَ مِن قَبْلِكُمْ لَعَلَّكُمْ تَتَّقُونَ
(184) أَيَّامًا مَّعْدُودَاتٍ فَمَن كَانَ مِنكُم مَّرِيضًا أَوْ عَلَى سَفَرٍ فَعِدَّةٌ مِّنْ أَيَّامٍ أُخَرَ وَعَلَى الَّذِينَ يُطِيقُونَهُ فِدْيَةٌ طَعَامُ مِسْكِينٍ فَمَن تَطَوَّعَ خَيْرًا فَهُوَ خَيْرٌ لَّهُ وَأَن تَصُومُواْ خَيْرٌ لَّكُمْ إِن كُنتُمْ تَعْلَمُونَ
(185) شَهْرُ رَمَضَانَ الَّذِيَ أُنزِلَ فِيهِ الْقُرْآنُ هُدًى لِّلنَّاسِ وَبَيِّنَاتٍ مِّنَ الْهُدَى وَالْفُرْقَانِ فَمَن شَهِدَ مِنكُمُ الشَّهْرَ فَلْيَصُمْهُ وَمَن كَانَ مَرِيضًا أَوْ عَلَى سَفَرٍ فَعِدَّةٌ مِّنْ أَيَّامٍ أُخَرَ يُرِيدُ اللّهُ بِكُمُ الْيُسْرَ وَلاَ يُرِيدُ بِكُمُ الْعُسْرَ وَلِتُكْمِلُواْ الْعِدَّةَ وَلِتُكَبِّرُواْ اللّهَ عَلَى مَا هَدَاكُمْ وَلَعَلَّكُمْ تَشْكُرُونَ

4. Recommendations for Management of Diabetes During Ramadan
Diabetes Care
Volume 33, Number 8, August 2010

5. Major risk associated with fasting in patients with diabetes
Hypoglycemia
Hyperglycemia
Diabetic ketoacidosis
Dehydration and thrombosis
Recommendations for Diabetic Individuals during Ramadan, Diabetes Care , vol 33, num. 8, August2010

6. Hypoglycaemia 2 – 4% of mortality in patients with type 1 diabetes.
Rates of hypoglycaemia are some several-fold lower in patients with type 2 compared with type 1 diabetes
Rates being lower in patients with type 2 diabetes treated with oral agents.
Recommendations for Diabetic Individuals during Ramadan, Diabetes Care , vol 33, num. 8, August2010

7. Categories of risks in patients with type 1 or type 2 diabetes who fast during Ramadan
1. Very high risk
Severe hypoglycaemia within the last 3 months prior to Ramadan.
A history of recurrent hypoglycaemia.
Hypoglycaemia unawareness.
Sustained poor glycemic control.
Ketoacidosis within the last 3 months prior to Ramadan.
Recommendations for Diabetic Individuals during Ramadan, Diabetes Care , vol 33, num. 8, August2010

8. Breaking the Fast
All patients must always and immediately end their fast if:
Hypoglycaemia (blood glucose of <60mg/dl).
Blood glucose reaches <70 mg in the first few hours after the start of the fast, especially if insulin, sulfonylurea drugs, or neglitinide are taken at predawn.
Blood glucose exceeds 300 mg with symptoms of hyperglycaemia.
Recommendations for Diabetic Individuals during Ramadan, Diabetes Care , vol 33, num. 8, August2010

9. (4.7 fold)
(7.5 fold)

10. Change in outcome measures during Ramadan in participants receiving both gliclazide and metformin1
Hypoglycaemia in study control group on Metfromin + Gliclazide Ramadan 2008
Int J Clin Pract 2009; 63: 1446–50 10 10 10

11. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Hypoglycemia in Sulphonylurea-Treated Subjects with Type 2 Diabetes Undergoing Ramadan Fasting: A Five-Country Observational Study
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

12. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Objectives
To determine the incidence of hypoglycemia during Ramadan in Muslim subjects with type 2 diabetes treated with a sulphonylurea.
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

13. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Subjects & Methods
Eligible subjects
Muslim patients with type 2 diabetes treated with Sulphonylureas( Glimiperide, Glyclazide , or Glibenclamide)
With or without Metformin
Age ≥ 18 years old
Excluded subjects
Patients with Type 1 diabetes
Patients with Insulin treated type 2 diabetes
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

14. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Subjects & Methods
Subjects were recruited from 5 countries.
300 subjects were selected per country.
Diabetes Center in Holy Makkah and other centers from (UAE, India, Malaysia, and occupied Palestine ).
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

15. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Subjects & Methods
Patients were given a daily dairy card to record ..
any hypoglycemic symptoms and complications
The time from the start of hypoglycemic symptoms and the last meal and medications
Self monitor blood glucose
Need for assistance to treat hypos.
The fasting was broken or not.
Cards to be filled daily regardless of symptoms
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

16. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Subjects & Methods
The hypoglycemic events were further classified into..
- Symptomatic : (headache, sweating,
tremors, palpitation, etc..)
- Documented: symptomatic with BG ≤ 70 mg/dl.
- Severe: requiring medical or non- medical
assistance.
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

17. Patients Characteristic in the Study
Overall
(N=1378)
Glipizide
(n=29)
Glibenclamide (n=535)
Gliclazide
(n=386)
Glimepiride
(n=428)
729 (53 %)
12 (41 %)
263 (49 %)
225 (58 %)
229 (54 %)
Gender M
53.8 ± 10.0
58.1± 9.8
55.5 ± 10.0
53.7 ± 9.2
51.4 ± 10.1
Age at baseline, yrs
46.6 ± 9.9
45.0 ± 18.5
29.4 ± 10.0
29.0 ± 5.3
28.4 ± 5.2
BMI, kg/m2
46.6± 9.9
47.5 ± 10.0
46.9 ± 8.9
45.3 ± 9.6
Age at diabetes diagnosis, yrs
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

18. Sulponylurea use by country in the study
Overall
(N=1378)
Glipizide
(n=29)
Glibenclamide (n=535)
Gliclazide
(n=386)
Glimepiride
(n=428)
Country
396 (29%)
0 (0%)
107 (20%)
50 (13%)
239 (56%)
India
247 (18%)
29 (100%)
170 (32%)
48 (11%)
Occupied Palestine
355 (26%)
144 (27%)
182 (47%)
29 (7%)
Malaysia
363 (26%)
114 (37%)
141 (37%)
108 (25%)
Saudi Arabia
17 (1%)
13 (3%)
4 (1%)
UAE
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

19. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Results
The daily dairy card were returned by 1378 patients from total 1397 patients.
Symptomatic hypoglycemia was 40% in occupied Palestine and 10% in Saudi Arabia
Over all symptomatic hypoglycemic events were recorded in 271 subjects (19.7%)
Headache represent 14.5%, sweating 10.2%, tremors 8.5% and palpitation 7%.
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

20. Incidence of symptomatic hypoglycemia during Ramadan by countries
N of Patients
Countries
40%
Occupied Palestine
24%
Malaysia
18%
United Arab Emirates
13%
India
10%
Saudi Arabia
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

21. Incidence of hypoglycemia during Ramadan by type
Percentage (%)
Type of hypoglycemia 86
Symptomatic hypoglycemic events
3.6
Documented hypoglycemic events
3.7
Severe hypoglycemic events
6.7
Severe hypoglycemic events requiring medical assistance
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

22. Incidence of hypoglycemia during Ramadan by type
86%
6.7%
3.6%
3.7%
Symptomatic
hypoglycemic
events
Documented
hypoglycemic
events
Severe
hypoglycemic
events
Severe
hypoglycemic
events requiring
medical assistance
Type of hypoglycemia

23. Incidence of hypoglycemia during Ramadan by types of drug
Overall
(N=1378)
Glipizide
(n=29)
Glibenclamide (n=535)
Gliclazide
(n=386)
Glimepiride
(n=428)
N of patients (%)
271
19.7%
8 (27.6%)
137 (25.6%)
54 (14 %)
72 (16.8%)
Symptomatic hypoglycemic events 49
3.6%
0 (0.0%)
21 (3.9%)
11 (2.8%)
17 (4.0%)
Documented hypoglycemic events 92
6.7%
2 (6.9%)
58 (10.8%)
10 (2.6%)
22 (5.1%)
Severe hypoglycemic events 51
3.7%
36 (6.5%)
6 (1.6%)
10 (2.3%)
Severe hypoglycemic events requiring medical assistance
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

24. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Results
Symptomatic hypoglycemia events 1095
Documented hypoglycemic events were similar across all sulphonylurea groups 3.6%, .
Events not requiring medical assistance 3.7%
Events requiring assistance 6.7% .
Subjects experienced a serious complication 1.2% .
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

25. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Discussion
The incidence of severe hypoglycemia requiring medical or non medical assistance or hospitalization were less than other studies.
In the EPIDAR study, 2% of patients hospitalized in comparison to 0.5% in this study. (Diabetes Care 2004; )
Health care resources utilization, was less in this study. The less severe hypoglycemia events or better education regarding the symptoms could explain this.
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

26. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
The incidence of Hypoglycaemia in Muslim Type 2 Diabetics treated with Sitagliptin or a Sulphoylurea during Ramadan.
Aim
To compare the incidence of symptomatic hypoglycaemia with Sitagliptin or A Sulphonylurea during Ramadan.
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

27. Patients and study design
A prospective, open-label, randomised study.
6 countries, 43 clinical sites.
1243 patients of whom 1066 randomized to treatment.
Muslim Type 2 diabetics willing to fast Ramadan.
Age : > 18 Yrs.
Treated with a sulphonylurea for at least 3 months before study with or without metformin and had HbA1c < 10%.
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

28. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Pre-Randomization Treatment
Sulphonylurea
( n = 514 )
Sitagliptin
( n = 507 )
(35%)
(31%)
Glibenclamide
(35%)
(37%)
Glimepiride
(30%)
(32%)
Glicalazide
(8%)
Monotherapy
471 (92%)
(92%)
Dual ( SU + MET ), n (%)
4.0
Duration of SU Therapy* yrs
(15%)
(16%)
Experienced hypoglycaemia in 3 M before Ramadan
Data are expressed as frequency, n(%) or mean ± standard deviation unless otherwise indicated. *median
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

29. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Results
1066 patients randomised,
1021 enrolled in the study as they returned at least one complete diary.
Incidence of symptomatic hypoglycaemic events
- Sitagliptin group (5.1%)
- Sulphonylurea group (11.9).
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

30. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Results
Overall
Egypt
Palestien
Jordan
Lebanon
Saudi
Arabia
UAE
*n/N (%)
Sitagliptin
Sulphonylurea
5.1%
11.9% 0%
18.6%
10.3%
22.1%
6.7%
7.1%
9.9%
21.2%
0.5%
20.0%
*no of patients experiencing event
/N overall or in each country by treatment. (%)
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

31. Current Medical Research & Opinion Vol. 27, No. 6, 2011, 1237-1242
Results
Sulphonylurea
( n = 514 )
n (%) of patients
Experiencing event
Sitagliptin
( n = 507 )
n ( %) of patients
( 16.3% )
( 6.9% )
Symptomatic or asymptomatic hypoglycemic events
Severe hypoglycemic events
3 ( 0.6% )
( 0.2% )
Hypoglycemic events requiring non-medical assistance
Hypoglycemic events requiring medical assistance
* Types of hypoglycemic event defined in Methods
Current Medical Research & Opinion Vol. 27, No. 6, 2011,

32. Fear of hypoglycemia is a major concern for patients
Male
Female
Severe hypoglycemia
Male
Female
Mild hypoglycemia
Male
Female
Kidney problems
Pramming et al. evaluated the frequency of symptomatic hypoglycemic episodes in 411 randomly selected conventionally treated T1DM outpatients.1
Between two consecutive visits to the outpatient clinic, each patient filled in a questionnaire at home. The number of hypoglycemic episodes was then recorded prospectively in a diary for one week. From the questionnaires, the (retrospective) frequencies of mild and severe symptomatic hypoglycemia were 1.6 and episodes/patient/week. From the diaries, the (prospective) frequencies of mild and severe hypoglycemic episodes were 1.8 and 0.027/patient/week. Symptomatic hypoglycemia was more frequent on working days than during weekends (1.8:1) and more frequent in the morning than during the afternoon, evening, and night (4.5:2.2:1.4:1).
The study showed that during their diabetic life, 36% of the patients had experienced hypoglycemic coma and that severity of hypoglycemia was their biggest concern in managing their diabetes.
This slide shows the relative degrees of fear towards different complications of diabetes, as reported by the study population using a visual analog scale.
Reference
Pramming S, Thorsteinsson B, Bendtson I et al. Symptomatic hypoglycemia in 411 type 1 diabetic patients. Diabet Med 1991;8:217–222.
Blindness
Male
Female
Very worried
Not worried
1. Pramming S et al. Diabet Med 1991;8:217–222 32

34. Hypoglycaemic Events
X4 increase

35. VECTOR: Aim and objectives
Main aim
To determine the incidence of hypoglycaemic events in 100 Muslim patients with T2D fasting during Ramadan, who are treated with dual therapy of metformin plus vildagliptin or metformin plus sulphonylurea (SU)
Primary objectives
the incidence of hypoglycaemic events defined as:
Any reported symptoms by the patient and/or any blood glucose measurement of less than 3.9 mmol/L (also defined as mild or Grade 1 hypoglycaemia)
The need for third party assistance (also defined as severe or Grade 2 hypoglycaemia);
Secondary objectives
the change in weight;
the change in HbA1c levels; and
the treatment adherence during Ramadan.

36. VECTOR: Results - Hypoglycaemic events (HE)
Mean between-group difference in patients who experienced at least one HE was –41·7% (p = 0·0002)
* P =
¥ p= 36

37. The between group difference was −0·6% (p = 0·0262)
VECTOR: HbA1c
VECTOR
The between group difference was −0·6% (p = 0·0262)
(7·7% to 7·2%)
(7·2% vs 7·3%)

38. :Adherence
VECTOR
Only 1 patient in the Vildagliptin group missed at least one dose, compared with 10 patients in the SU group.
p = 0·0204

39. * There are an estimated 325,000 Muslims with type 2 diabetes in the UK
** Hypoglycemic event (defined as blood glucose < 3.5 mmol ⁄ l with or without symptoms)

40. References:
1. Devendra D et al. Vildagliptin therapy and hypoglycaemia in Muslim type 2 diabetes patients during Ramadan. Int J Clin Pract, October 2009, 63, 10, 1446–1450.

42. How to Help Patients Fast Safely
Patient Education Program.
Select more safe drugs.
Adjust dose if needed
Ensure good non – sugar fluid intake.
Avoid heavy physical exercise at afternoon.
Ensure good calorie distribution.

43. استشارة مجانية في شهر رمضان
جــوال :

44. THANK YOU

45. Thank you