Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT00044694
Last Updated: 2015-02-20
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
156 participants
INTERVENTIONAL
2002-08-31
2003-05-31
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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Placebo 0.01 mL
2 week placebo lead-in followed by Placebo 0.01 mL
Placebo 0.01 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily
Placebo 0.02 mL
2 week placebo lead-in followed by Placebo 0.02 mL
Placebo 0.02 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily
Placebo 0.03 mL
2 week placebo lead-in followed by Placebo 0.03 mL
Placebo 0.03 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily
Placebo 0.04 mL
2 week placebo lead-in followed by Placebo 0.04 mL
Placebo 0.04 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily
AC2993 2.5 mcg
2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL
AC2993 2.5 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily
AC2993 5.0 mcg
2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL
AC2993 5.0 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily
AC2993 7.5 mcg
2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL
AC2993 7.5 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily
AC2993 10.0 mcg
2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL
AC2993 10.0 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily
Interventions
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Placebo 0.01 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily
Placebo 0.02 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily
Placebo 0.03 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily
Placebo 0.04 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily
AC2993 2.5 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily
AC2993 5.0 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily
AC2993 7.5 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily
AC2993 10.0 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treated with diet and exercise alone or with metformin for at least 3 months prior to screening
* BMI 27-45 kg/m\^2
* HbA1c between 7.0 % and 8.0 %
Exclusion Criteria
* Patients previously treated with AC2993
* Patients presently treated with insulin
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Innovative Clinical Trials
Birmingham, Alabama, United States
Healthsouth Clinical Research
Birmingham, Alabama, United States
Endocrinology Clinic of O.C.
Anaheim, California, United States
Pioneer Medical Group
Bellflower, California, United States
International Clinical Research Network
Chula Vista, California, United States
Bautista Research and Medical Clinic
Fresno, California, United States
Whittier Institute for Diabetes
La Jolla, California, United States
Richard Cherlin, M.D.
Los Gatos, California, United States
Dr. Martinez Medical Clinic
Moreno Valley, California, United States
Anshutz Outpatient Pavilion
Aurora, Colorado, United States
Diagnostic Clinic
Clearwater, Florida, United States
Radiant Research-Gainsville
Gainsville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Radiant Research-Pinellas Park
Pinellas Park, Florida, United States
Clinical Research Group of North Georgia
Blairsville, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Radiant Research-Honolulu
Honolulu, Hawaii, United States
Radiant Research-Boise
Boise, Idaho, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Northshore Medical Research, LLC
Covington, Louisiana, United States
Medical Research Institute
Slidell, Louisiana, United States
Melvin Kramer, MD
Concord, Massachusetts, United States
Radiant Research-Edina
Edina, Minnesota, United States
Mississippi Medical Research, LLC
Gulfport, Mississippi, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Innovative Health Research
Las Vegas, Nevada, United States
Carolina Advanced Research
Cary, North Carolina, United States
Fallen Timbers Internal Medicine, LLC
Maumee, Ohio, United States
Millenium Research
Benbrook, Texas, United States
Healthsouth Clinical Research
DeSoto, Texas, United States
Baylor College of Medicine/Clinical Studies Unit
Houston, Texas, United States
Diabetes Center of the Southwest
Midland, Texas, United States
Utah Diabetes Center at the University of Utah
Salt Lake City, Utah, 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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2993-116
Identifier Type: -
Identifier Source: org_study_id
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