Effect of Exenatide on 24-Hour Blood Glucose Profile Compared with Placebo in Patients with Type 2 Diabetes
Study identifier:H8O-US-GWAW
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Effect of Exenatide on 24-Hour Blood Glucose Profile Compared with Placebo in Patients with Type 2 Diabetes Using Metformin or Metformin Plus a Thiazolidinedione
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 2
Healthy volunteers
No
Study drug
exenatide, Placebo
Sex
All
Actual Enrollment
30
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Oct 2005
Primary Completion Date: 01 Jun 2007
Study Completion Date: 01 Jun 2007
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
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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| Arms | Assigned Interventions |
|---|---|
| Experimental: Exenatide Exenatide and the subject's current oral antidiabetic agent regimen | Drug: exenatide subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week Other Name: Byetta Other Name: AC2993 Other Name: synthetic enxendin-4 |
| Placebo Comparator: Placebo Placebo and the subject's current oral antidiabetic agent regimen | Drug: Placebo subcutaneous injection, equivalent volume to 5 mcg exenatide twice a day for one week; then equivalent volume to 10 mcg exenatide twice a day for one week |
Contacts
Investigators
Principal Investigator
James Malone
Eli Lilly and Company
