Study identifier:D1680C00009
ClinicalTrials.gov identifier:NCT02273050
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control
Type 2 Diabetes Mellitus
Phase 3
No
Saxagliptin 5 mg, Placebo 5 mg for Saxagliptin, Placebo 500 mg for metformin (with titration), Metformin 500 mg with titration
All
1136
Interventional
18 Years - 100 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Aug 2017 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Saxagliptin 5 mg + Metformin (500 mg with titration) Saxagliptin 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed. | Drug: Saxagliptin 5 mg Tablet, Oral, 5 mg, Once daily in the morning Other Name: Onglyza Other Name: BMS-477118 Drug: Metformin 500 mg with titration Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration. Other Name: Glucophage |
Active Comparator: Saxagliptin 5 mg + Placebo Saxagliptin 5 mg once daily and Placebo 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed. | Drug: Saxagliptin 5 mg Tablet, Oral, 5 mg, Once daily in the morning Other Name: Onglyza Other Name: BMS-477118 Drug: Placebo 500 mg for metformin (with titration) Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration. |
Active Comparator: Metformin (500 mg with titration) + Placebo Placebo 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed. | Drug: Placebo 5 mg for Saxagliptin Tablet, Oral, 5 mg, Once daily in the morning Drug: Metformin 500 mg with titration Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration. Other Name: Glucophage |