Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects with Type 2 Diabetes
Study identifier:2993-119
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects with Type 2 Diabetes Mellitus
Medical condition
Diabetes Mellitus, Type 2
Phase
Phase 3
Healthy volunteers
No
Study drug
exenatide
Sex
All
Actual Enrollment
456
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 01 Nov 2002
Primary Completion Date: 01 Sept 2006
Study Completion Date: 01 Sept 2006
Study design
Allocation: N/A
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
N/A
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Exenatide Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination | Drug: exenatide subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination Other Name: Byetta Other Name: exendin-4 Other Name: AC2993 |
Contacts
Investigators
Principal Investigator
Lisa Porter
Amylin Pharmaceuticals
