Diabetes Mellitus, Type 2 Clinical Trial
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
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).
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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