A Phase III Randomised, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Fix Dose Combination of Linagliptin 2.5 mg + Metformin 500 mg, or of Linagliptin 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg, Twice Daily), and Linagliptin (5.0 mg, Once Daily) Over 24 Weeks in Treatment naïve Type 2 Diabetic Patients With Insufficient Glycaemic Control
Abstract
Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients
Conditions: Diabetes Mellitus, Type 2.
Primary outcome: The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group; The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC); The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG.
Enrollment: 876 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 876 participants or records.
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