Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, Dipeptidyl-Peptidase 4 Inhibitors, Saxagliptin, Metformin, Endocrine System Diseases
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1136
Healthy volunteers: no

Brief summary:
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

Detailed description:
Allocation: Randomized Endpoint Classification: Efficacy/Safety study Intervention Model: Parallel Assignment Masking: Double Blind Primary Purpose: Treatment

Arms:
arm 1: Saxagliptin 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed. arm 2: Saxagliptin 5 mg once daily and Placebo 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed. arm 3: Placebo 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed.

Interventions: intervention 1: Saxagliptin 5 mg intervention 2: Placebo 5 mg for Saxagliptin intervention 3: Placebo 500 mg for metformin (with titration) intervention 4: Metformin 500 mg with titration
Intervention descriptions: intervention 1: Tablet, Oral, 5 mg, Once daily in the morning intervention 2: Tablet, Oral, 5 mg, Once daily in the morning intervention 3: Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration. intervention 4: Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

Protocol document: