Study identifier:CV181-363
ClinicalTrials.gov identifier:NCT02284893
EudraCT identifier:2014-001102-17
CTIS identifier:N/A
A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial with a Blinded 26-week Long -term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin in Combination with Metformin Compared to Sitagliptin in Combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Type 2 Diabetes
Phase 3
No
Saxagliptin, Dapagliflozin, Sitagliptin, Placebo matching with Saxagliptin, Placebo matching with Dapagliflozin, Placebo matching with Sitagliptin
All
461
Interventional
18 Years - 120 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 May 2018 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: A1:Saxagliptin / Placebo + Dapagliflozin / Placebo Saxagliptin 5 mg and matching placebo 0 mg (once daily) plus Dapagliflozin 10 mg and matching placebo 0 mg (once daily) | Drug: Saxagliptin administered orally once daily Drug: Dapagliflozin administered orally once daily Drug: Placebo matching with Saxagliptin administered orally once daily Drug: Placebo matching with Dapagliflozin administered orally once daily |
Experimental: A2: Sitagliptin / placebo Sitagliptin 100 mg and matching placebo 0 mg (once daily) | Drug: Sitagliptin administered orally once daily Drug: Placebo matching with Sitagliptin administered orally once daily |