Safety and Efficacy of Exenatide as Monotherapy
1 other identifier
interventional
233
5 countries
19
Brief Summary
This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes-mellitus
Started Sep 2006
Shorter than P25 for phase_3 type-2-diabetes-mellitus
19 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
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 25, 2006
CompletedFirst Posted
Study publicly available on registry
September 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFebruary 23, 2015
January 1, 2015
1 year
September 25, 2006
February 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24
Change in HbA1c from Baseline to Week 24
Baseline, Week 24
Secondary Outcomes (6)
Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less
Baseline, Weeks 4, 8, 12, 16, 24
Change in fasting serum glucose (FSG) from Baseline to Week 24
Baseline, Weeks 4, 8, 12, 16, and 24
Change in body weight from Baseline to Week 24
Baseline, Weeks 4, 8, 12, 16, and 24
Change in glucose measurements from Baseline to Week 24
Baseline, Weeks 4, 8, 12, 16, 24
Changes in beta-cell function and insulin sensitivity from Baseline to Week 24
Baseline, Weeks 4, 8, 12, 16, and 24
- +1 more secondary outcomes
Study Arms (3)
Exenatide 5 mcg/exenatide 5 mcg
EXPERIMENTALExenatide 5 mcg; then exenatide 5 mcg
Exenatide 5 mcg/exenatide 10 mcg
EXPERIMENTALExenatide 5 mcg, then exenatide 10 mcg
Placebo
PLACEBO COMPARATORPlacebo in volumes equivalent to exenatide
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with type 2 diabetes
- Treating diabetes with diet and exercise
- HbA1c between 6.5% and 10.0%, inclusive
- Body Mass Index (BMI) between 25 kg/m\^2 and 45 kg/m\^2, inclusive
You may not qualify if:
- Have previously completed or withdrawn from this study
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Have been treated with any antidiabetic agent
- Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening
- Are currently treated with any of the following excluded medications: \* drugs that directly affect gastrointestinal motility; \* systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (19)
Research Site
Idaho Falls, Idaho, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Aligarh, India
Research Site
Bangalore, India
Research Site
Chennai, India
Research Site
Indore, India
Research Site
Karnāl, India
Research Site
New Delhi, India
Research Site
Vellore, India
Research Site
Manatí, Puerto Rico
Research Site
San Juan, Puerto Rico
Research Site
Alba Iulia, Romania
Research Site
Baia Mare, Romania
Research Site
Bucharest, Romania
Research Site
Galati, Romania
Research Site
Oradea, Romania
Research Site
Târgu Mureş, Romania
Research Site
Moscow, Russia
Research Site
Saint Petersburg, Russia
Related Publications (3)
Moretto TJ, Milton DR, Ridge TD, Macconell LA, Okerson T, Wolka AM, Brodows RG. Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2008 Aug;30(8):1448-60. doi: 10.1016/j.clinthera.2008.08.006.
PMID: 18803987RESULTPencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
PMID: 22913891DERIVEDFineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
PMID: 22236356DERIVED
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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2006
First Posted
September 27, 2006
Study Start
September 1, 2006
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
February 23, 2015
Record last verified: 2015-01