- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00387972
Study Of Denagliptin In Subjects With Type 2 Diabetes Mellitus (T2DM)
April 15, 2015 updated by: GlaxoSmithKline
A Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Denagliptin in Subjects With Type 2 Diabetes Mellitus
GW823093 is a selective DPP-IV Inhibitor and is being investigated as a once a day oral therapy.
The purpose of the Study is to evaluate the effectiveness, safety, and tolerability of 2 doses of GW823093, compared to placebo, taken once daily in patients with Type 2 diabetes mellitus.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Tallassee, Alabama, United States, 36078
- GSK Clinical Trials Call Center
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Arizona
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Phoenix, Arizona, United States, 85016
- GSK Clinical Trials Call Center
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Tucson, Arizona, United States, 85710
- GSK Clinical Trials Call Center
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California
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Beverly Hills, California, United States, 90211
- GSK Clinical Trials Call Center
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Carmichael, California, United States, 95608
- GSK Clinical Trials Call Center
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Concord, California, United States, 94520-2054
- GSK Clinical Trials Call Center
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Torrance, California, United States, 90505
- GSK Clinical Trials Call Center
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Victorville, California, United States, 92392
- GSK Clinical Trials Call Center
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Delaware
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Wilmington, Delaware, United States, 19805
- GSK Clinical Trials Call Center
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Florida
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Boynton Beach, Florida, United States, 33435
- GSK Clinical Trials Call Center
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Clearwater, Florida, United States, 33765
- GSK Clinical Trials Call Center
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Coral Gables, Florida, United States, 33134
- GSK Clinical Trials Call Center
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Hialeah, Florida, United States, 33010
- GSK Clinical Trials Call Center
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Hollywood, Florida, United States, 33023
- GSK Clinical Trials Call Center
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Melbourne, Florida, United States, 32901
- GSK Clinical Trials Call Center
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Miami, Florida, United States, 33169
- GSK Clinical Trials Call Center
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Opalocka, Florida, United States, 33054
- GSK Clinical Trials Call Center
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Plantation, Florida, United States, 33324
- GSK Clinical Trials Call Center
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Tampa, Florida, United States, 33609
- GSK Clinical Trials Call Center
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Georgia
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Calhoun, Georgia, United States, 30701
- GSK Clinical Trials Call Center
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Roswell, Georgia, United States, 30076
- GSK Clinical Trials Call Center
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Idaho
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Hayden Lake, Idaho, United States, 83835-2108
- GSK Clinical Trials Call Center
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Illinois
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Chicago, Illinois, United States, 60610
- GSK Clinical Trials Call Center
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Chicago, Illinois, United States, 60616
- GSK Clinical Trials Call Center
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Lake Zurich, Illinois, United States, 60047
- GSK Clinical Trials Call Center
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Watseka, Illinois, United States, 60970
- GSK Clinical Trials Call Center
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- GSK Clinical Trials Call Center
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Marrero, Louisiana, United States, 70072
- GSK Clinical Trials Call Center
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Maryland
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Oxon Hill, Maryland, United States, 20745
- GSK Clinical Trials Call Center
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Michigan
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Detroit, Michigan, United States, 48235
- GSK Clinical Trials Call Center
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Missouri
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Florissant, Missouri, United States, 63031
- GSK Clinical Trials Call Center
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St. Louis, Missouri, United States, 63128
- GSK Clinical Trials Call Center
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St. Peters, Missouri, United States, 63376
- GSK Clinical Trials Call Center
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Nevada
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Las Vegas, Nevada, United States, 89128
- GSK Clinical Trials Call Center
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New York
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Williamsville, New York, United States, 14221
- GSK Clinical Trials Call Center
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North Carolina
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Charlotte, North Carolina, United States, 28277
- GSK Clinical Trials Call Center
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Morehead City, North Carolina, United States, 28557
- GSK Clinical Trials Call Center
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North Dakota
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Fargo, North Dakota, United States, 58103
- GSK Clinical Trials Call Center
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Ohio
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Cincinnati, Ohio, United States, 45219
- GSK Clinical Trials Call Center
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Columbus, Ohio, United States, 43207
- GSK Clinical Trials Call Center
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Oklahoma
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Guthrie, Oklahoma, United States, 73044
- GSK Clinical Trials Call Center
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Norman, Oklahoma, United States, 73069
- GSK Clinical Trials Call Center
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Oklahoma City, Oklahoma, United States, 73112-5550
- GSK Clinical Trials Call Center
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Oklahoma City, Oklahoma, United States, 73116
- GSK Clinical Trials Call Center
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Yukon, Oklahoma, United States, 73112
- GSK Clinical Trials Call Center
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Oregon
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Eugene, Oregon, United States, 97404
- GSK Clinical Trials Call Center
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Medford, Oregon, United States, 97504
- GSK Clinical Trials Call Center
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Pennsylvania
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Beaver Falls, Pennsylvania, United States, 15010
- GSK Clinical Trials Call Center
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Fleetwood, Pennsylvania, United States, 19522
- GSK Clinical Trials Call Center
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Warminster, Pennsylvania, United States, 18974
- GSK Clinical Trials Call Center
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South Carolina
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Anderson, South Carolina, United States, 29621
- GSK Clinical Trials Call Center
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- GSK Clinical Trials Call Center
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Johnson City, Tennessee, United States, 37601
- GSK Clinical Trials Call Center
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Texas
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Cleburne, Texas, United States, 76033
- GSK Clinical Trials Call Center
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San Antonio, Texas, United States, 78205
- GSK Clinical Trials Call Center
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Seguin, Texas, United States, 78155
- GSK Clinical Trials Call Center
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Virginia
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Weber City, Virginia, United States, 24290
- GSK Clinical Trials Call Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Type 2 diabetes mellitus treated with diet and exercise or oral anti-diabetic treatment
- Body mass index between 20 and 40
- Females of childbearing potential must use adequate birth control.
Exclusion criteria:
- Subjects with previous use of insulin
- Type 1 diabetes
- Uncontrolled thyroid disease
- History of drug or alcohol abuse in the past year
- Any other clinically significant disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change from baseline in blood glucose regulation after 26 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
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Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: GSK Clinical Trial, DM, FRCP, GlaxoSmithKline
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Anticipated)
October 1, 2007
Study Completion (Anticipated)
October 1, 2007
Study Registration Dates
First Submitted
October 12, 2006
First Submitted That Met QC Criteria
October 12, 2006
First Posted (Estimate)
October 13, 2006
Study Record Updates
Last Update Posted (Estimate)
April 17, 2015
Last Update Submitted That Met QC Criteria
April 15, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DPB107246
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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