Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT00085969
Last Updated: 2015-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2003-09-30
2004-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A1 - Placebo 0.04 mL twice daily
Placebo 0.04 mL twice daily
Subcutaneously injected, 0.04 mL, twice daily
A2 - Placebo 0.04 mL once daily
Placebo 0.04 mL once daily
Subcutaneously injected, 0.04 mL, once daily
A3 - Placebo 0.08 mL once daily
Placebo 0.08 mL once daily
Subcutaneously injected, 0.08 mL, once daily
B - Exenatide 10 mcg twice daily
B - Exenatide 10 mcg twice daily
Subcutaneously injected, 10 mcg (0.04 mL), twice daily
C - Exenatide 10 mcg once daily
C - Exenatide 10 mcg once daily
Subcutaneously injected, 10 mcg (0.04 mL), once daily
D - Exenatide 20 mcg once daily
Exenatide 20 mcg once daily
Subcutaneously injected, 20 mcg (0.08 mL), once daily
Interventions
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Placebo 0.04 mL twice daily
Subcutaneously injected, 0.04 mL, twice daily
Placebo 0.04 mL once daily
Subcutaneously injected, 0.04 mL, once daily
Placebo 0.08 mL once daily
Subcutaneously injected, 0.08 mL, once daily
B - Exenatide 10 mcg twice daily
Subcutaneously injected, 10 mcg (0.04 mL), twice daily
C - Exenatide 10 mcg once daily
Subcutaneously injected, 10 mcg (0.04 mL), once daily
Exenatide 20 mcg once daily
Subcutaneously injected, 20 mcg (0.08 mL), once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subject is currently treated with any of the following excluded medications: (a) Metformin/sulfonylurea combination therapy (b) Thiazolidinediones (c) Insulin as outpatient therapy (d) Regular use of drugs that directly affect gastrointestinal motility (e) Regular use of systemic corticosteroids by oral, intravenous (IV), or intramuscular (IM) route, or potent, inhaled, intrapulmonary, or intranasal steroids known to have a high rate of systemic absorption (f) Regular use of medications with addictive potential such as opiates, narcotics and tranquilizers (g) Antineoplastic agents (h) Transplantation medications (i) Prescription weight-loss medications.
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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The Whittier Institute for Diabetes
La Jolla, California, United States
VA Medical Center
San Diego, California, United States
MedStar Research Institute
Washington D.C., District of Columbia, United States
Internal Medicine Associates, Department of Research
Fort Myers, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Innovative Research of West Florida
Largo, Florida, United States
Henry Ford Health System
Detroit, Michigan, United States
Grand Rapids Associated Internists
Grand Rapids, Michigan, United States
Radiant Research, Inc.
St Louis, Missouri, United States
Internal Medicine Associates
Bozeman, Montana, United States
Mercury Street Medical Group
Butte, Montana, United States
Lovelace Scientific Resources
Las Vegas, Nevada, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Metrolina Medical Research
Charlotte, North Carolina, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
Radiant Research
Columbus, Ohio, United States
Smith Clinic Research
Marion, Ohio, United States
Radiant Research
Portland, Oregon, United States
Philadelphia Health Associates - Adult Medicine
Philadelphia, Pennsylvania, United States
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, United States
S.A.M. Clinical Research Center
San Antonio, Texas, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Rockwood Clinic
Spokane, Washington, United States
Countries
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References
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Nelson 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.
Other Identifiers
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2993-120
Identifier Type: -
Identifier Source: org_study_id
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