drugset / Trial / NCT00258804

Insulin Glargine During and After the Period of Fasting in Ramadan

NCT00258804 ↗

Phase 4 Completed 450 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2005-05
Primary completion
2006-02
Completion
2006-02

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic — —