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

October 12, 2006
November 8, 2006
May 2006
Not Provided
Change from baseline in blood glucose regulation after 26 weeks of treatment
Same as current
Complete list of historical versions of study NCT00387972 on ClinicalTrials.gov Archive Site
Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: denagliptin (GW823093)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
450
Not Provided
Not Provided

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00387972
DPB107246
Not Provided
Not Provided
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trial, DM, FRCP GlaxoSmithKline
GlaxoSmithKline
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP