Efficacy and Safety of Dapagliflozin and Dapagliflozin plus Saxagliptin in Combination with Metformin in Type 2 Diabetes Patients compared with Sulphonylurea
Study identifier:D1689C00014
ClinicalTrials.gov identifier:NCT02471404
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin plus Saxagliptin compared with Sulphonylurea all given as Add-on Therapy to Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy
Medical condition
Type 2 diabetes mellitus,
Phase
Phase 4
Healthy volunteers
No
Study drug
Dapagliflozin, Saxagliptin, Glimepiride, Placebo for dapagliflozin, Placebo for saxagliptin, Placebo for glimepiride
Sex
All
Actual Enrollment
939
Study type
Interventional
Age
18 Years - 74 Years
Date
Study Start Date: 21 Sept 2015
Primary Completion Date: 13 Mar 2017
Study Completion Date: 13 Mar 2017
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2018 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Dapagliflozin+metformin Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin | Drug: Dapagliflozin 10 mg, 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 Drug: Placebo for glimepiride Does not contain active ingredient, orally. Opaque gray capsule |
| Active Comparator: Dapagliflozin+saxagliptin+metformin Dapagliflozin + saxagliptin + glimepiride placebo+ metformin | Drug: Dapagliflozin 10 mg, orally Green, plain, diamond-shaped, film-coated tablet Other Name: Forxiga Drug: Saxagliptin 5 mg, orally Plain, yellow, biconvex, round, film-coated tablet Other Name: Onglyza™ Drug: Placebo for glimepiride Does not contain active ingredient, orally. Opaque gray capsule |
| Active Comparator: Glimepiride+metformin Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin | Drug: Glimepiride 1, 2, or 4 mg, orally Opaque gray capsule Other Name: Amaryl Drug: Placebo for dapagliflozin Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet Drug: Placebo for saxagliptin Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet |
