Study identifier:D1683C00005
ClinicalTrials.gov identifier:NCT02681094
EudraCT identifier:N/A
CTIS identifier:N/A
A Multi-Center, Randomized, Double-Blind, Active-Controlled , Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin 5mg Co-administered with Dapagliflozin 5mg compared to Saxagliptin 5mg or Dapagliflozin 5mg all given as Add-on Therapy to Metformin inPatients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Alone
Type 2 Diabetes Mellitus
Phase 3
No
Dapagliflozin, Placebo for Dapagliflozin, Saxagliptin, Placebo for Saxagliptin
All
905
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Sept 2018 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Saxagliptin+Dapagliflozin+Metformin 5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin | Drug: Dapagliflozin 5mg, orally, Green, plain, diamond-shaped, film-coated tablet Other Name: Forxiga Drug: Saxagliptin 5mg, orally, Plain, yellow, biconvex, round, film-coated tablet Other Name: Onglyza™ |
Active Comparator: Dapagliflozin+Saxagliptin placebo+Metformin 5 mg Tablets, Oral, Once daily, 24 weeks for Dapagliflozin and Saxagliptin Placebo | Drug: Dapagliflozin 5mg, orally, Green, plain, diamond-shaped, film-coated tablet Other Name: Forxiga Drug: Placebo for Saxagliptin Does not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet |
Active Comparator: Saxagliptin+Dapagliflozin placebo+metformin 5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin placebo | Drug: Placebo for Dapagliflozin Does not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet Drug: Saxagliptin 5mg, orally, Plain, yellow, biconvex, round, film-coated tablet Other Name: Onglyza™ |