Study identifier:CV181-365
ClinicalTrials.gov identifier:NCT02419612
EudraCT identifier:N/A
CTIS identifier:N/A
A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial with a Blinded 104-week Long -term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin in combination with Metformin Compared to Glimepiride in Combination with Metformin ≥1500 mg in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
diabetes
Phase 3
No
Saxagliptin, Dapagliflozin, Glimepiride
All
444
Interventional
18 Years - 120 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jun 2020 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally | - |
Experimental: Glimepiride or Placebo Glimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally | - |