Overview

Insulin Glargine During and After the Period of Fasting in Ramadan

Status:
Completed
Trial end date:
2006-02-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 4
Details
Lead Sponsor:
Sanofi
Treatments:
Insulin
Insulin Glargine
Insulin, Globin Zinc