Insulin Glargine During and After the Period of Fasting in Ramadan
|ClinicalTrials.gov Identifier: NCT00258804|
Recruitment Status : Completed
First Posted : November 28, 2005
Last Update Posted : June 8, 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).
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Insulin glargine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2005|
|Primary Completion Date :||February 2006|
|Study Completion Date :||February 2006|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258804
|Study Director:||Patrick SINNASSAMY, MD||Sanofi|