A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients with Type 2 Diabetes
Study identifier:H8O-MC-GWCD
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients with Type 2 Diabetes
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 3
Healthy volunteers
No
Study drug
exenatide, placebo
Sex
All
Actual Enrollment
54
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Sept 2007
Primary Completion Date: 01 Apr 2008
Study Completion Date: 01 Apr 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Eli Lilly and Company
Inclusion and exclusion criteria
Location
Research Site
Toronto, Ontario, Canada
Location
Research Site
Halifax, Nova Scotia, Canada
Location
Research Site
Etten-Leur, Netherlands
Location
Research Site
Utrecht, Netherlands
Location
Research Site
Rotterdam, Netherlands
Location
Research Site
Leiden, Netherlands
| Arms | Assigned Interventions |
|---|---|
| Experimental: Exenatide Arm This arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study. | Drug: exenatide subcutaneous injection, 5mcg or 10mcg, twice a day Other Name: Byetta Other Name: AC2993 Other Name: LY2148568 |
| Placebo Comparator: Placebo Arm This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm). | Drug: placebo subcutaneous injection, volume equivalent to active, twice a day |
Contacts
Contact
AstraZeneca Clinical Study Information Center Support Center
Investigators
Principal Investigator
Chief Medical Officer
Eli Lilly and Company
