Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes
An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
456
1 country
60
Brief Summary
This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus-type-2
Started Nov 2002
Longer than P75 for phase_3 diabetes-mellitus-type-2
60 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
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 23, 2005
CompletedFirst Posted
Study publicly available on registry
May 24, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFebruary 23, 2015
January 1, 2015
3.8 years
May 23, 2005
February 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit
Change in HbA1c from Visit 1 to each visit up to open-ended study termination
Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Change in body weight from Visit 1 to each protocol visit
Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination
Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Change in fasting plasma glucose from Visit 1 to each protocol visit
Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination
Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Change in lipids from Visit 1 to each protocol visit
Change in lipids from Visit 1 to each visit up to open-ended study termination
Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Study Arms (1)
Exenatide
EXPERIMENTALExenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination
Interventions
subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination
Eligibility Criteria
You may qualify if:
- The subject has an HbA1c value \<=11.0%
- The subject has a body mass index (BMI) of 25 kg/m\^2 to 45 kg/m\^2, inclusive
You may not qualify if:
- Is currently treated with certain medications, including exogenous insulin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (60)
Research Site
Birmingham, Alabama, United States
Research Site
Anaheim, California, United States
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Bellflower, California, United States
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Burlingame, California, United States
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Chula Vista, California, United States
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Concord, California, United States
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Encino, California, United States
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Fremont, California, United States
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La Jolla, California, United States
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Los Gatos, California, United States
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Moreno Valley, California, United States
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Redwood City, California, United States
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San Mateo, California, United States
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Walnut Creek, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Largo, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Blairsville, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Lexington, Kentucky, United States
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Covington, Louisiana, United States
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New Orleans, Louisiana, United States
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Slidell, Louisiana, United States
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Detroit, Michigan, United States
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Edina, Minnesota, United States
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Minneapolis, Minnesota, United States
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Gulfport, Mississippi, United States
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Picayune, Mississippi, United States
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Chesterfield, Missouri, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Las Vegas, Nevada, United States
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New York, New York, United States
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Rochester, New York, United States
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Cary, North Carolina, United States
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Durham, North Carolina, United States
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Columbus, Ohio, United States
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Marion, Ohio, United States
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Maumee, Ohio, United States
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Mentor, Ohio, United States
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Clinton, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Camp Hill, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Midland, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Olympia, Washington, United States
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Spokane, Washington, United States
Related Publications (5)
Blonde L, Klein EJ, Han J, Zhang B, Mac SM, Poon TH, Taylor KL, Trautmann ME, Kim DD, Kendall DM. Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes. Diabetes Obes Metab. 2006 Jul;8(4):436-47. doi: 10.1111/j.1463-1326.2006.00602.x.
PMID: 16776751RESULTBuse JB, Klonoff DC, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Maggs DG, Wintle ME. Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials. Clin Ther. 2007 Jan;29(1):139-53. doi: 10.1016/j.clinthera.2007.01.015.
PMID: 17379054RESULTKlonoff DC, Buse JB, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Wintle ME, Maggs DG. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin. 2008 Jan;24(1):275-86. doi: 10.1185/030079908x253870.
PMID: 18053320RESULTFineman 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: 22236356DERIVEDNelson P, Poon T, Guan X, Schnabel C, Wintle M, Fineman M. The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Diabetes Technol Ther. 2007 Aug;9(4):317-26. doi: 10.1089/dia.2006.0024.
PMID: 17705687DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa Porter, MD
Amylin Pharmaceuticals, LLC.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2005
First Posted
May 24, 2005
Study Start
November 1, 2002
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
February 23, 2015
Record last verified: 2015-01