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, Saxagliptin, Metformin XR, Metformin XR, Metformin XR, Dapagliflozin, 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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| 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
