The Efficacy and Safety of Glimepiride in the Management of Type 2 Diabetes in Muslim Patients During Ramadan

The study included Muslim subjects aged 35–65 years with type 2 diabetes who presented good metabolic control with glimepiride in monotherapy for at least 3 months before Ramadan and were willing to participate in daylight fasting throughout the month of Ramadan. Subjects were excluded if they had no authorization to fast according to the Ramadan consensus recommendations (8), known hypersensitivity to glimepiride, diabetic ketoacidosis, progressive fatal disease, type 1 diabetes, or type 2 diabetes treated with insulin. Women who were pregnant or breastfeeding were also excluded from the study.

This was an open-label, prospective, observational study carried out in 33 centers in six countries (Algeria, Egypt, Indonesia, Jordan, Lebanon, and Malaysia).

Each subject attended a baseline visit at inclusion (V0) and three follow-up visits: V1 just before, or no more than 5 days after, the start of Ramadan (6 November 2002), V2 at the end of Ramadan (5 December 2002), and V3 between 45 and 75 days after the end of Ramadan.

During the two maintenance periods, pre- and post-Ramadan, subjects took glimepiride as usually prescribed, once daily before the first main meal of the morning. During Ramadan, the time of administration was switched to before the first meal after sunset without changing the dose.

The primary objective of the study was to monitor HbA_1c and fasting blood glucose (FBG) levels at V0, V1, and V3. The number of hypoglycemic events, either symptomatic or based on self-monitoring of blood glucose (defined as <70 mg/dl), was recorded for each period of the study.

Glycemic control was compared between newly diagnosed subjects (diagnosed in the 6 months preceding inclusion) and subjects already being treated for type 2 diabetes.

The study was conducted according to the Declaration of Helsinki (Hong Kong Amendment), Good Clinical Practices, and pertinent national legal and regulatory requirements.

A total of 100 newly diagnosed and 232 already-treated subjects were included in the study between June and October 2002. The demographic characteristics and diabetes history of this population at baseline are given in Table 1. Few diabetes-related complications were reported, all of which concerned patients in the group that was already treated.

HbA_1c values (% ± SD) measured at V0, V1, and V3 were 9.2 ± 1.7, 7.7 ± 1.2, and 7.1 ± 0.9, respectively, in the newly diagnosed subjects and 8.4 ± 1.8, 7.7 ± 1.5, and 7.3 ± 1.3, respectively, in the subjects who were already treated.

The mean FBG value at the baseline visit (9.5 ± 3.2 mmol/l) decreased to 7.0 ± 1.7 mmol/l by the end of the study. As found with HbA_1c, FBG values were higher for the newly diagnosed subjects (10.4 ± 2.8 mmol/l) than for the group that was already treated (9.1 ± 3.3 mmol/l) at baseline, but by the end of the study these values were very similar (6.9 ± 1.2 mmol/l in newly diagnosed and 7.1 ± 1.9 mmol/l in already treated).

Reported hypoglycemic events ranged from 25 (in 13 subjects) in pre-Ramadan to 15 (in 11 subjects) during Ramadan and 8 (in 8 subjects) in post-Ramadan periods. The majority of these subjects were from the group already treated.

Our results show that the efficacy and safety of glimepiride in type 2 diabetic patients is not altered during the month-long daylight fast of Ramadan, when the time of administration of glimepiride is changed from the morning to the evening. During Ramadan the incidence of hypoglycemic episodes was 3% in newly diagnosed patients and 3.7% in already-treated patients. These figures were similar to the pre- and post-Ramadan periods. These results are consistent with those of other published studies (9,10).

It can be concluded that with careful dietary management and a change in the time of drug administration from morning to evening, Muslim type 2 diabetic patients taking glimepiride who are normally well controlled can fast during Ramadan if they wish to do so, with no deterioration of glycemic control.

This study was supported by a grant from Aventis Intercontinental, manufacturers of glimepiride.

Members of the GLIRA (Glimepiride in Ramadan) Study Group are as follows.

Benaziez Khadija, Meguerbi Maamoun, and Oussalah Khaled (Algeria); El-Gyar Hisham, Mahgoub Moghazy, Rashwan Raefat, Shelbaya Salah, and Zyada Assem (Egypt); Arnaout Mohammed, El-Khalil Nidal, El-Tarazi Ramzi, Haddad Jihad, Makke Oussama, and Snounou Hassan (Jordan); Manaf Asman and Ayu Kshanti Ida (Indonesia); Abd Kadir Khalid, Embong Mustaffa, Wan Bebakar, Khalid Wan Mohamad (Malaysia); Awada Nazih, Echtay Akram, El-Rachidi Ziad, El-Sayadi Abdel Wahab, El-Zein Camille, Farran Sami, Fliti Fadl, Ghazzawi Ahmad, Haidar Said, Jabali Yahya, Karaouni Abdel Karim, Krayem Marwan, Mansour Mamdouh, Rahhal Haitham, Mouawad Dolly, Mrad Ali, Nazer Hicham, and Youssef Issam (Lebanon).