Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents
Study identifier:H8O-MC-GWAK
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Exploratory Study of the Safety of Substituting Exenatide for Insulin in Patients With Type 2 Diabetes Who Have Been Using Insulin in Combination With Oral Antidiabetic Therapy
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 2
Healthy volunteers
No
Study drug
exenatide, Insulin
Sex
All
Actual Enrollment
49
Study type
Interventional
Age
35 Years - 70 Years
Date
Study Start Date: 01 Feb 2004
Primary Completion Date: 01 Aug 2005
Study Completion Date: 01 Aug 2005
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Eli Lilly and Company
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Exenatide The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy. | Drug: exenatide Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks. Other Name: synthetic exendin-4 Other Name: AC2993 Other Name: Byetta |
| Active Comparator: Insulin The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy. | Drug: Insulin Insulin will be taken according to the subject's current regimen |
Contacts
Investigators
Principal Investigator
James Malone
Eli Lilly and Co.
