Insulin Glargine During and After the Period of Fasting in Ramadan
This study has been completed.
Information provided by:
First received: November 24, 2005
Last updated: June 7, 2011
Last verified: June 2011
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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.
|Study Start Date:||May 2005|
|Study Completion Date:||February 2006|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
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