A 24-week Open-Label, Phase 3b Trial with a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes who have Glycemic Control on Metformin
Study identifier:CV181-369
ClinicalTrials.gov identifier:NCT02551874
EudraCT identifier:2015-001702-33
CTIS identifier:N/A
Study Complete
Official Title
A 24-week International, Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Group, Phase 3b Trial with a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin Compared to Insulin Glargine in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin with or without Sulfonylurea Therapy
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 3
Healthy volunteers
No
Study drug
Saxagliptin, Onglyza, Dapagliflozin, Farxiga, Glargine insulin, Metformin
Sex
All
Actual Enrollment
650
Study type
Interventional
Age
18 Years - 120 Years
Date
Study Start Date: 20 Oct 2015
Primary Completion Date: 08 May 2017
Study Completion Date: 10 Nov 2017
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2018 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Saxagliptin/Dapagliflozin/Metformin Oral route. Saxagliptin/Dapa adminsitered once daily for 24 weeks at a dose of 5 mg Saxagliptin and 10 mg Dapagliflozin | Drug: Saxagliptin, Onglyza Tablets, Oral, 5mg , Once daily, 24 weeks Other Name: Onglyza Drug: Dapagliflozin, Farxiga Tablets, Oral, 10mg , Once daily, 24 weeks Other Name: BMS-512148 Drug: Metformin Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks Other Name: Glucophage |
| Active Comparator: Insulin Glargine, Lantos/Metformin Insulin glargine administered once a day with starting dose of 0.2 Unit per kg or 10 units. | Drug: Glargine insulin 100 Units/ml solution for injection in a prefilled SoloStar pen Other Name: Lantus |
Contacts
Investigators
Principal Investigator
AstraZeneca
AstraZeneca
