Phase 3 28-Week study with 24-Week and 52-week extension phases to evaluate efficacy and safety of Exenatide once weekly and Dapagliflozin versus Exenatide and Dapagliflozin matching placebo
Study identifier:D5553C00003
ClinicalTrials.gov identifier:NCT02229396
EudraCT identifier:2014-003503-29
CTIS identifier:N/A
Study Complete
Official Title
A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study with a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin
Medical condition
Diabetes Mellitus
Phase
Phase 3
Healthy volunteers
No
Study drug
Exantide with Dapagliflozin, Exentide, Dapagliflozin
Sex
All
Actual Enrollment
695
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 04 Sept 2014
Primary Completion Date: 26 Apr 2016
Study Completion Date: 28 Dec 2017
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2018 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg | Drug: Exantide with Dapagliflozin 2 mg weekly suspension injection and 10 mg Dapagliflozin |
| Experimental: Exenatide Once Weekly 2 mg Alone | Drug: Exentide 2 mg |
| Active Comparator: Dapagliflozin Once Daily 10 mg Alone | Drug: Dapagliflozin 10 mg once daily Dapagliflozin |
