A Multinational, Open Label, Non Comparative, 24-week Study to Evaluate the Blood Glucose Lowering Efficacy and Safety of a Fixed Dose Combination of Glimepiride and Metformin in Patients With Inadequately Controlled Type 2 Diabetes
Abstract
Primary Objective:
-To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus.
Secondary Objective:
To assess the effects of the fixed combination of glimepiride and metformin at week 24 on:
* Percentage of patients reaching HbA1c \<7%
* Percentage of patients reaching HbA1c \<6.5%.
* Fasting Plasma Glucose (FPG)
* Safety and tolerability
Conditions: Type 2 Diabetes Mellitus.
Primary outcome: Change in HbA1c.
Enrollment: 167 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 167 participants or records.
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