Phase III study to evaluate safety and efficacy of added exenatide versus placebo to titrated basal insulin Glargine in inadequately controlled patients with type II diabetes mellitus
Study identifier:D5553C00002
ClinicalTrials.gov identifier:NCT02229383
EudraCT identifier:2014-003502-33
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine with or without Metformin
Medical condition
Diabetes Mellitus
Phase
Phase 3
Healthy volunteers
No
Study drug
Exenatide, Exenatide matching placebo
Sex
All
Actual Enrollment
464
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 06 Sept 2014
Primary Completion Date: 29 Aug 2016
Study Completion Date: 29 Aug 2016
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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| Arms | Assigned Interventions |
|---|---|
| Experimental: Exenatide Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin | Drug: Exenatide 2 mg weekly suspension injection |
| Placebo Comparator: Placebo Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin | Drug: Exenatide matching placebo Once weekly Placebo injection |
