Efficacy and safety of insulin glargine and glimepiride in subjects with Type 2 diabetes before, during and after the period of fasting in Ramadan.

AIMS: To determine the safety and efficacy of insulin glargine and glimepiride in patients with Type 2 diabetes before and after Ramadan and during fasting for Ramadan.

METHODS: In this open, descriptive, multi-centre, prospective study, insulin-naïve (n = 100) or previously insulin-treated (n = 249) patients with Type 2 diabetes received insulin glargine [titrated from 10 U daily according to fasting blood glucose (FBG)] and glimepiride (4 mg daily). The number and type of hypoglycaemic episodes and glycaemic control were assessed before, during and after Ramadan. Bivariate logistic regression analyses were used to identify factors which predicted hypoglycaemia during Ramadan.

RESULTS: Only one episode of severe hypoglycaemia occurred in each time period before, during and after Ramadan. Mild hypoglycaemic episodes increased from 156 pre-Ramadan to 346 during Ramadan (P < 0.001) and decreased to 153 post-Ramadan (P = 0.0002).The increase during Ramadan was mainly attributed to increased symptomatic hypoglycaemic episodes. FBG and glycated haemoglobin improved during the titration period and did not change during the rest of the study. Risk of hypoglycaemic events during Ramadan was higher in countries where fasting is strict [odds ratio (OR) 3.69 (2.06-6.63), P < 0.0001]. Lower weight [< 70.0 kg; OR 2.56 (1.46-4.48), P = 0.001] and waist circumference [< 90 cm; OR 3.06 (1.62-5.78), P = 0.001] increased the risk of hypoglycaemia during Ramadan whilst FBG > 6.7 mmol/l [OR 0.3 (0.17-0.54), P < 0.0001] had a protective effect.

CONCLUSIONS: Combination of insulin glargine and glimepiride may be used during Ramadan in patients with Type 2 diabetes who wish to fast, provided glimepiride is given at the time of breaking the fast and insulin glargine titrated to provide FBG > 6.7 mmol/l.