Safety and Efficacy of Combination Saxagliptin & Dapagliflozin added to Metformin to Treat Subjects with Type 2 Diabetes
Study identifier:CV181-169
ClinicalTrials.gov identifier:NCT01606007
EudraCT identifier:2012-000679-18
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy with Saxagliptin and Dapagliflozin added to Metformin compared to Add-On Therapy with Saxagliptin in combination with Metformin or Dapagliflozin in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone.
Medical condition
Type 2 Diabetes
Phase
Phase 3
Healthy volunteers
No
Study drug
Saxagliptin, Metformin XR, Dapagliflozin, Placebo matching with Dapagliflozin, Placebo matching with Saxagliptin
Sex
All
Actual Enrollment
1282
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jul 2012
Primary Completion Date: 01 Jan 2014
Study Completion Date: 01 Jan 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2017 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Astra Zeneca
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Arm 1: Saxagliptin+Metformin XR+Placebo | Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Name: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Name: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks |
| Active Comparator: Arm 2: Dapagliflozin+Metformin XR+Placebo | Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Name: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Name: BMS-512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks |
| Experimental: Arm 3: Saxagliptin+Dapagliflozin+Metformin XR | Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Name: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Name: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Name: BMS-512148 |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
