Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258804
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-11-24
Brief Title:
Insulin Glargine During and After the Period of Fasting in Ramadan
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None