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
-
This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.
Location
Location
Kromeriz, Czech Republic, 767 01
Location
Cheb, Czech Republic, 350 02
Location
Nachod, Czech Republic, 54701
Location
Praha 4, Czech Republic, 149 00
Location
Praha 4, Czech Republic, 140 00
Location
Krnov, Czech Republic, 794 01
Location
Hradec Kralove, Czech Republic, 503 41
Location
Dresden, Germany, 01307
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 | - |
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