Study Stopped
Study cancelled before enrollment
Study Of Denagliptin In Subjects With Type 2 Diabetes Mellitus (T2DM)
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
1 other identifier
interventional
N/A
1 country
57
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2006
Typical duration for phase_2 type-2-diabetes-mellitus
57 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
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 12, 2006
CompletedFirst Posted
Study publicly available on registry
October 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedApril 17, 2015
April 1, 2015
1.4 years
October 12, 2006
April 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in blood glucose regulation after 26 weeks of treatment
Secondary Outcomes (1)
Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (57)
GSK Clinical Trials Call Center
Tallassee, Alabama, 36078, United States
GSK Clinical Trials Call Center
Phoenix, Arizona, 85016, United States
GSK Clinical Trials Call Center
Tucson, Arizona, 85710, United States
GSK Clinical Trials Call Center
Beverly Hills, California, 90211, United States
GSK Clinical Trials Call Center
Carmichael, California, 95608, United States
GSK Clinical Trials Call Center
Concord, California, 94520-2054, United States
GSK Clinical Trials Call Center
Torrance, California, 90505, United States
GSK Clinical Trials Call Center
Victorville, California, 92392, United States
GSK Clinical Trials Call Center
Wilmington, Delaware, 19805, United States
GSK Clinical Trials Call Center
Boynton Beach, Florida, 33435, United States
GSK Clinical Trials Call Center
Clearwater, Florida, 33765, United States
GSK Clinical Trials Call Center
Coral Gables, Florida, 33134, United States
GSK Clinical Trials Call Center
Hialeah, Florida, 33010, United States
GSK Clinical Trials Call Center
Hollywood, Florida, 33023, United States
GSK Clinical Trials Call Center
Melbourne, Florida, 32901, United States
GSK Clinical Trials Call Center
Miami, Florida, 33169, United States
GSK Clinical Trials Call Center
Opa-locka, Florida, 33054, United States
GSK Clinical Trials Call Center
Plantation, Florida, 33324, United States
GSK Clinical Trials Call Center
Tampa, Florida, 33609, United States
GSK Clinical Trials Call Center
Calhoun, Georgia, 30701, United States
GSK Clinical Trials Call Center
Roswell, Georgia, 30076, United States
GSK Clinical Trials Call Center
Hayden Lake, Idaho, 83835-2108, United States
GSK Clinical Trials Call Center
Chicago, Illinois, 60610, United States
GSK Clinical Trials Call Center
Chicago, Illinois, 60616, United States
GSK Clinical Trials Call Center
Lake Zurich, Illinois, 60047, United States
GSK Clinical Trials Call Center
Watseka, Illinois, 60970, United States
GSK Clinical Trials Call Center
Baton Rouge, Louisiana, 70809, United States
GSK Clinical Trials Call Center
Marrero, Louisiana, 70072, United States
GSK Clinical Trials Call Center
Oxon Hill, Maryland, 20745, United States
GSK Clinical Trials Call Center
Detroit, Michigan, 48235, United States
GSK Clinical Trials Call Center
City of Saint Peters, Missouri, 63376, United States
GSK Clinical Trials Call Center
Florissant, Missouri, 63031, United States
GSK Clinical Trials Call Center
St Louis, Missouri, 63128, United States
GSK Clinical Trials Call Center
Las Vegas, Nevada, 89128, United States
GSK Clinical Trials Call Center
Williamsville, New York, 14221, United States
GSK Clinical Trials Call Center
Charlotte, North Carolina, 28277, United States
GSK Clinical Trials Call Center
Morehead City, North Carolina, 28557, United States
GSK Clinical Trials Call Center
Fargo, North Dakota, 58103, United States
GSK Clinical Trials Call Center
Cincinnati, Ohio, 45219, United States
GSK Clinical Trials Call Center
Columbus, Ohio, 43207, United States
GSK Clinical Trials Call Center
Guthrie, Oklahoma, 73044, United States
GSK Clinical Trials Call Center
Norman, Oklahoma, 73069, United States
GSK Clinical Trials Call Center
Oklahoma City, Oklahoma, 73112-5550, United States
GSK Clinical Trials Call Center
Oklahoma City, Oklahoma, 73116, United States
GSK Clinical Trials Call Center
Yukon, Oklahoma, 73112, United States
GSK Clinical Trials Call Center
Eugene, Oregon, 97404, United States
GSK Clinical Trials Call Center
Medford, Oregon, 97504, United States
GSK Clinical Trials Call Center
Beaver Falls, Pennsylvania, 15010, United States
GSK Clinical Trials Call Center
Fleetwood, Pennsylvania, 19522, United States
GSK Clinical Trials Call Center
Warminster, Pennsylvania, 18974, United States
GSK Clinical Trials Call Center
Anderson, South Carolina, 29621, United States
GSK Clinical Trials Call Center
Chattanooga, Tennessee, 37404, United States
GSK Clinical Trials Call Center
Johnson City, Tennessee, 37601, United States
GSK Clinical Trials Call Center
Cleburne, Texas, 76033, United States
GSK Clinical Trials Call Center
San Antonio, Texas, 78205, United States
GSK Clinical Trials Call Center
Seguin, Texas, 78155, United States
GSK Clinical Trials Call Center
Weber City, Virginia, 24290, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trial, DM, FRCP
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 12, 2006
First Posted
October 13, 2006
Study Start
May 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
April 17, 2015
Record last verified: 2015-04