Gliclazide MR, an Efficacy and Safety

for T2DM Patients During Ramadan

Djoko W Soeatmadji
 During Ramadan in Indonesia:
91% T2DM Patients Fast > 15 Days
% of patients who fast > 15 days
Algeria 92
Bangladesh 95
Egypt 91
India 83 From Dawn
Indonesia 91
Jordan 88
Lebanon 78
Malaysia 95 ≈ +13 hrs
Morocco 83
Pakistan 77
Saudi Arabia 89
Tunisia 73 To Dusk
Turkey 73
0 20 40 60 80 100
Salti I,et al.Diabetes Care 2004;27:2306-11
Fasting Not Feasting!
In fact, Indonesian eat more during Ramadhan!
What’s Suitable SU in
Ramadan?
EFFICACY SAFETY

PREVENTION OF COMPLICATIONS

GOOD
Diabetes Care
 Gliclazide MR Provide Strong Glycemic Control
Before, During, & After Ramadan

Zargar AH, et al. Int J Clin Pract 2010;64(8):1090-4

 Meta Analysis published
in Diabetes Metabolism Research
& Reviews

Objective:
A meta analysis of 25 clinical trials,
including 8,480 type 2 diabetic patients,
to determine the proportion of
hypoglycemia when treated with
different SUs.

Diabetes Metab Res Rev 2014; 30: 11–22.

 Hypoglycemia was 9 to 11 times less with
gliclazide compared to glimepiride

Diabetes Metab Res Rev 2014; 30: 11–22.

Hypoglycemia Risk vs.
DPP-4 inhibitor
 SU vs. DPP-4 inhibitor during RAMADAN

Original paper published in IJCP

(International Journal of Clinical
Practice)

Objective:
To compare the incidence of hypoglycemia in
Muslim fasting type 2 diabetic patients (from
Middle East) treated with DPP-4 inhibitor or
SU in Ramadan.

Int J Clin Pract, November 2011, 65, 11, 1132–1140

 Comparing the incidence of symptomatic hypoglycemia
with sitagliptin or a sulfonylurea during Ramadan

• The incidence of Hypoglycaemia in Muslim Type 2 Diabetics treated with Sitagliptin

or a Sulphonylurea during Ramadan1
• Hypoglycemia in Patients With Type 2 Diabetes From India and Malaysia Treated
with Sitagliptin or a Sulfonylurea During Ramadan: A Randomized, Pragmatic
Study2
Study Design (n) Medication Key endpoint(s) Symptomatic
hypoglycaemia*
Al Sifri et al1 Randomised, open-label, Sitagliptin Incidence of symptomatic Sita: 6.7%
pragmatic study (1,021) SU (gliclazide, glimepiride hypoglycaemia SU: 13.2%
or glibenclamide) ± Met

Aravind et al2 Randomised, open-label Sitagliptin Incidence of symptomatic Sita: 3.8%

pragmatic study (848) SU (gliclazide, glimepiride hypoglycaemia SU: 7.3%
or glibenclamide) ± Met

*Symptoms with or without confirmatory blood glucose

DPP-4, dipeptidyl peptidase-4; HbA1c, glycosylated haemoglobin; Met, metformin, NA, not assessed; Sita, sitagliptin; SU, sulfonylurea
1. Al Sifri S, et al. Int J Clin Pract 2011;65:1132-40; 2. Aravind SR, et al. Curr Med Res Opin 2012;28:1289-96
 OAD Hypoglycemia (%)
Glibenclamide 19.7
Glimepiride 12.4
Sitagliptin 6.7
Gliclazide MR 6.6

Mean dose s of SU were: 3.5mg in the morning and 3.1mg in the evening for glimepiride; 71.9mg and 89.0mg
for gliclazide; 6.1mg and 5.9mg for glibenclamide

1. Al Sifri S, et al. Int J Clin Pract 2011;65:1132-40

 T2DM During Ramadan Incidence of Hypoglycemia
Gliclazide vs DPP 4i – Meta-analysis

Objective:
A meta analysis of 3 randomized trials, including 2,426 fasting type 2 diabetic
patients; to assess the incidence of hypoglycemia among patients treated with
gliclazide MR or DPP-4 inhibitors.
Diabetes Res Clin Pract. 2015;109:226-232
 Gliclazide MR Ensures
Low Risk of Hypoglycemia, Similar to DPP-4i

Mbanya JC et al. Diabetes Res Clin Pract. 2015;109(2):226-232.

Why Gliclazide MR Different
with Other SUs?
Why the lower risk of hypoglycaemia with
gliclazide?

1. Insulin secretion from β cell is glucose dependent

2. Insulin secretion dependent on reversibility of

binding to ATP sensitive potassium channels on β
cell
 A Unique Structure of Gliclazide MR
Aminoazabicyclo-octyl ring Absence of benzamido moiety

Antioxidant properties
Reversible binding
 A glucose-dependent insulin secretion
• Gliclazide unlike glimepiride and
glibenclamide, binds reversibly to the β-
cell receptor.

Diamicron MR 60 mg

Glimepiride
Glibenclamide

Ashcroft FM, Gribble FM. J Diabetes Complications. 2000;14(4):192-196.

 A glucose-dependent insulin secretion

• Gliclazide MR, unlike glimepiride and

glibenclamide, binds reversibly to the β-
cell receptor.

Diamicron MR 60 mg

Glimepiride
Glibenclamide

Ashcroft FM, Gribble FM. J Diabetes Complications. 2000;14(4):192-196.

 A glucose-dependent insulin secretion

• Gliclazide MR, unlike glimepiride and

glibenclamide, binds reversibly to the β-
cell receptor.

Ashcroft FM, Gribble FM. J Diabetes Complications. 2000;14(4):192-196.

 A glucose-dependent insulin secretion

• Gliclazide MR, unlike glimepiride and

glibenclamide, binds reversibly to the β-
cell receptor.
NORMOGLYCEMIA

Ashcroft FM, Gribble FM. J Diabetes Complications. 2000;14(4):192-196.

 A glucose-dependent insulin secretion

• Gliclazide MR, unlike glimepiride and

glibenclamide, binds reversibly to the β-
cell receptor.
NORMOGLYCEMIA

Ashcroft FM, Gribble FM. J Diabetes Complications. 2000;14(4):192-196.

First modified release scored formulation
(patented till 2028)
Gliclazide Differentiation vs Other SUs
 Safely Evening Administration
of Diamicron MR 60 During Ramadan

Hypoglycemic Episodes

Before Ramadan 5 3.7%

During Ramadan 3 2.2%

After Ramadan 2 1.5%

CONCLUSION:
Male patients under glycemic control with DIAMICRON MR 60 monotherapy can safely
maintain the same degree of control by switching to an evening dose schedule
during Ramadan. The frequency of hypoglycaemia is low, and weight gain minimal

Zargar AH, et al. Int J Clin Pract 2010;64(8):1090-4

 KEY MESSAGES

• Key risks associated with fasting for patients with diabetes :

Hypoglycemia, Hyperglycemia, Dehydration, Ketoacidosis
• Gliclazide MR provide optimal efficacy before, during, and after
Ramadan
• Risk of hypoglycemia is not significant with gliclazide vs. DPP-4
inhibitor
• Gliclazide is consider as effective and safe SU in patients with type
2 diabetes fasting during Ramadan