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

Sanofi0 sites450 target enrollmentMay 2005

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: Sanofi
Enrollment: 450
Primary Endpoint: Glycemic control before, during and after Ramadan in terms of HbA1c, FBG, 8-point blood glucose profile
Status: Completed
Last Updated: 14 years ago

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).

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

February 2006

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•Pregnancy (as determined by pregnancy blood test at inclusion visit)
•Breast- feeding
•Women of childbearing potential who do not have adequate contraceptive protection
•Need for treatment during the study period with medications that may interfere with the study protocol
•Treatment with any investigational drug (only if in trial) in the last 3 months before entry into the study
•History of drug or alcohol abuse
•Severe and unbalanced diabetic retinopathy
•Clinically relevant cardiovascular, gastrointestinal, hepatic, renal, neurological, endocrine, hematological or other major systemic diseases that may interfere with the study protocol or complicate the interpretation of study results
•Night shift workers