Evaluation (Safety and Efficacy) of Treatment With Insulin Glargine and Glimepiride in Patients With Type 2 Diabetes Before, During and After the Period of Fasting in Ramadan

NCT00258804 Phase 4 COMPLETED

Primary Objectives : * To compare the number of hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) in patients with type 2 diabetes treated with insulin glargine (Lantus®) and glimepiride (Amaryl®), before, during and after the period of fasting in Ramadan. Secondary Objectives : * To assess glycaemic control before, during and after Ramadan in terms of HbA1c, FBG, and 8-point blood glucose profile (FBG and 8-point blood glucose profile will be collected with a blood glucose monitor through a monthly patient diary). * To assess the relationship between hypoglycaemia events during Ramadan and blood glucose control prior and during Ramadan. * To assess patient satisfaction * To document adverse events (all serious adverse events, non serious adverse events) throughout the study (all events will be collected through the monthly patient diary).

Details

Lead sponsor	Sanofi
Phase	Phase 4
Status	COMPLETED
Enrolment	450
Start date	2005-05
Completion	2006-02

Conditions

• Diabetes Mellitus, Type 2

Interventions

• Insulin glargine

Primary outcomes

• Hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) before, during and after Ramadan
• Glycemic control before, during and after Ramadan in terms of HbA1c, FBG, 8-point blood glucose profile
• All other adverse events before, during and after Ramadan
• Patient satisfaction before, during and after Ramadan.