Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes
1 other identifier
interventional
30
1 country
2
Brief Summary
The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 type-2-diabetes-mellitus
Started Oct 2005
Typical duration for phase_2 type-2-diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 17, 2005
CompletedFirst Posted
Study publicly available on registry
October 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedFebruary 23, 2015
January 1, 2015
1.7 years
October 17, 2005
February 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time-averaged serum glucose during a 24-hour period
Time-averaged serum glucose during a 24-hour period
Every half-hour to hour for 24 hours
Secondary Outcomes (1)
To compare the effects of exenatide and placebo on serum glucose
Each half-hour to 2 hours for 24 hours
Study Arms (2)
Exenatide
EXPERIMENTALExenatide and the subject's current oral antidiabetic agent regimen
Placebo
PLACEBO COMPARATORPlacebo and the subject's current oral antidiabetic agent regimen
Interventions
subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week
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
Eligibility Criteria
You may qualify if:
- Subject has an HbA1c between 7.0% and 10.0%, inclusive.
- Subject has a body mass index (BMI) \>25 kg/m\^2 and \<50 kg/m\^2.
- Subject is on a stable dose of metformin or metformin plus a thiazolidinedione.
You may not qualify if:
- Subject has been treated with any of the following medications: \*exogenous insulin for more than 1 week within 3 months of screening, \*sulfonylureas or meglitinides within 2 months of screening, \*alpha-glucosidase inhibitors within 2 months of screening, \*pramlintide acetate injection within 2 months of screening.
- Subject has received exenatide, GLP-1 analogs, DPP-IV inhibitors, or has participated in this study previously.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (2)
Research Site
Washington D.C., District of Columbia, United States
Research Site
San Antonio, Texas, United States
Related Publications (1)
Brodows RG, Qu Y, Johns D, Kim D, Holcombe JH. Quantifying the effect of exenatide and insulin glargine on postprandial glucose excursions in patients with type 2 diabetes. Curr Med Res Opin. 2008 May;24(5):1395-7. doi: 10.1185/030079908x297268. Epub 2008 Apr 3.
PMID: 18394265DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Malone, MD
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2005
First Posted
October 19, 2005
Study Start
October 1, 2005
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
February 23, 2015
Record last verified: 2015-01