Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT00258804
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).
Study:
NCT00258804
Study Brief:
Protocol Section:
NCT00258804