Study Of Denagliptin In Subjects With Type 2 Diabetes Mellitus (T2DM)

This study has suspended participant recruitment.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00387972
First received: October 12, 2006
Last updated: November 8, 2006
Last verified: November 2006
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: denagliptin (GW823093)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in blood glucose regulation after 26 weeks of treatment

Secondary Outcome Measures:
  • Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures

Estimated Enrollment: 450
Study Start Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387972

  Hide Study Locations
Locations
United States, Alabama
GSK Clinical Trials Call Center
Tallassee, Alabama, United States, 36078
United States, Arizona
GSK Clinical Trials Call Center
Phoenix, Arizona, United States, 85016
GSK Clinical Trials Call Center
Tucson, Arizona, United States, 85710
United States, California
GSK Clinical Trials Call Center
Beverly Hills, California, United States, 90211
GSK Clinical Trials Call Center
Carmichael, California, United States, 95608
GSK Clinical Trials Call Center
Concord, California, United States, 94520-2054
GSK Clinical Trials Call Center
Torrance, California, United States, 90505
GSK Clinical Trials Call Center
Victorville, California, United States, 92392
United States, Delaware
GSK Clinical Trials Call Center
Wilmington, Delaware, United States, 19805
United States, Florida
GSK Clinical Trials Call Center
Boynton Beach, Florida, United States, 33435
GSK Clinical Trials Call Center
Clearwater, Florida, United States, 33765
GSK Clinical Trials Call Center
Coral Gables, Florida, United States, 33134
GSK Clinical Trials Call Center
Hialeah, Florida, United States, 33010
GSK Clinical Trials Call Center
Hollywood, Florida, United States, 33023
GSK Clinical Trials Call Center
Melbourne, Florida, United States, 32901
GSK Clinical Trials Call Center
Miami, Florida, United States, 33169
GSK Clinical Trials Call Center
Opalocka, Florida, United States, 33054
GSK Clinical Trials Call Center
Plantation, Florida, United States, 33324
GSK Clinical Trials Call Center
Tampa, Florida, United States, 33609
United States, Georgia
GSK Clinical Trials Call Center
Calhoun, Georgia, United States, 30701
GSK Clinical Trials Call Center
Roswell, Georgia, United States, 30076
United States, Idaho
GSK Clinical Trials Call Center
Hayden Lake, Idaho, United States, 83835-2108
United States, Illinois
GSK Clinical Trials Call Center
Chicago, Illinois, United States, 60610
GSK Clinical Trials Call Center
Chicago, Illinois, United States, 60616
GSK Clinical Trials Call Center
Lake Zurich, Illinois, United States, 60047
GSK Clinical Trials Call Center
Watseka, Illinois, United States, 60970
United States, Louisiana
GSK Clinical Trials Call Center
Baton Rouge, Louisiana, United States, 70809
GSK Clinical Trials Call Center
Marrero, Louisiana, United States, 70072
United States, Maryland
GSK Clinical Trials Call Center
Oxon Hill, Maryland, United States, 20745
United States, Michigan
GSK Clinical Trials Call Center
Detroit, Michigan, United States, 48235
United States, Missouri
GSK Clinical Trials Call Center
Florissant, Missouri, United States, 63031
GSK Clinical Trials Call Center
St. Louis, Missouri, United States, 63128
GSK Clinical Trials Call Center
St. Peters, Missouri, United States, 63376
United States, Nevada
GSK Clinical Trials Call Center
Las Vegas, Nevada, United States, 89128
United States, New York
GSK Clinical Trials Call Center
Williamsville, New York, United States, 14221
United States, North Carolina
GSK Clinical Trials Call Center
Charlotte, North Carolina, United States, 28277
GSK Clinical Trials Call Center
Morehead City, North Carolina, United States, 28557
United States, North Dakota
GSK Clinical Trials Call Center
Fargo, North Dakota, United States, 58103
United States, Ohio
GSK Clinical Trials Call Center
Cincinnati, Ohio, United States, 45219
GSK Clinical Trials Call Center
Columbus, Ohio, United States, 43207
United States, Oklahoma
GSK Clinical Trials Call Center
Guthrie, Oklahoma, United States, 73044
GSK Clinical Trials Call Center
Norman, Oklahoma, United States, 73069
GSK Clinical Trials Call Center
Oklahoma City, Oklahoma, United States, 73112-5550
GSK Clinical Trials Call Center
Oklahoma City, Oklahoma, United States, 73116
GSK Clinical Trials Call Center
Yukon, Oklahoma, United States, 73112
United States, Oregon
GSK Clinical Trials Call Center
Eugene, Oregon, United States, 97404
GSK Clinical Trials Call Center
Medford, Oregon, United States, 97504
United States, Pennsylvania
GSK Clinical Trials Call Center
Beaver Falls, Pennsylvania, United States, 15010
GSK Clinical Trials Call Center
Fleetwood, Pennsylvania, United States, 19522
GSK Clinical Trials Call Center
Warminster, Pennsylvania, United States, 18974
United States, South Carolina
GSK Clinical Trials Call Center
Anderson, South Carolina, United States, 29621
United States, Tennessee
GSK Clinical Trials Call Center
Chattanooga, Tennessee, United States, 37404
GSK Clinical Trials Call Center
Johnson City, Tennessee, United States, 37601
United States, Texas
GSK Clinical Trials Call Center
Cleburne, Texas, United States, 76033
GSK Clinical Trials Call Center
San Antonio, Texas, United States, 78205
GSK Clinical Trials Call Center
Seguin, Texas, United States, 78155
United States, Virginia
GSK Clinical Trials Call Center
Weber City, Virginia, United States, 24290
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trial, DM, FRCP GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00387972     History of Changes
Other Study ID Numbers: DPB107246
Study First Received: October 12, 2006
Last Updated: November 8, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Type 2 diabetes mellitus (T2DM)
glycosylated hemoglobin (HbA1c)
denagliptin
diabetes treatment
glycemic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014