Study identifier:D5553C00003
ClinicalTrials.gov identifier:NCT02229396
EudraCT identifier:2014-003503-29
CTIS identifier:N/A
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
Diabetes Mellitus
Phase 3
No
Exantide with Dapagliflozin, Exentide, Dapagliflozin
All
695
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Dec 2018 by AstraZeneca
AstraZeneca
-
Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.
Location
Location
Chicago, IL, United States, 60607
Location
North Miami Beach, FL, United States, 33162
Location
Clinton, UT, United States, 84015
Location
Houston, TX, United States, 77074
Location
Miami, FL, United States, 33175
Location
Orlando, FL, United States, 32801
Location
Richmond, VA, United States, 23294
Location
Tampa, FL, United States, 33603
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 |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.