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

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ClinicalTrials.gov Identifier: NCT00387972
Recruitment Status : Withdrawn (Study cancelled before enrollment)
First Posted : October 13, 2006
Last Update Posted : April 17, 2015
Sponsor:
Information provided by:

October 12, 2006
October 13, 2006
April 17, 2015
May 2006
October 2007   (Final data collection date for primary outcome measure)
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
Intervention Model: Parallel Assignment
Masking: Double
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.
 
Withdrawn
0
October 2007
October 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00387972
DPB107246
Not Provided
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trial, DM, FRCP GlaxoSmithKline
GlaxoSmithKline
April 2015

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