Insulin Glargine During and After the Period of Fasting in Ramadan
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|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)|
|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|
|Actual Primary Completion Date :||February 2006|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258804
|Study Director:||Patrick SINNASSAMY, MD||Sanofi|