Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects with Type 2 Diabetes - DURATION-NEO-1
Study identifier:BCB118
ClinicalTrials.gov identifier:NCT01652716
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus
Medical condition
Diabetes Mellitus, Type 2
Phase
Phase 3
Healthy volunteers
No
Study drug
Exenatide once weekly suspension, Exenatide twice daily
Sex
All
Actual Enrollment
377
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jan 2013
Primary Completion Date: 01 Aug 2014
Study Completion Date: 01 Aug 2014
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 May 2018 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Exenatide once weekly suspension Exenatide suspension 2 mg weekly subcutaneous injection | Drug: Exenatide once weekly suspension Exenatide suspension 2 mg weekly subcutaneous injection |
| Active Comparator: Exenatide twice daily (BID) Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks | Drug: Exenatide twice daily 5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks Other Name: Byetta |
Contacts
Contact
AstraZeneca Clinical Study Information Center Telephone no (US and Outside the US):
-
Investigators
Principal Investigator
Vice President Medical Research & Development
Amylin Pharmaceuticals, LLC
