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, Dapagliflozin, Saxagliptin, Glimepiride, Placebo for dapagliflozin, Placebo for saxagliptin, Placebo for saxagliptin, Placebo for glimepiride, 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
Loading...
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 |
