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

This study has been withdrawn prior to enrollment.
(Study cancelled before enrollment)
Information provided by:
GlaxoSmithKline Identifier:
First received: October 12, 2006
Last updated: April 15, 2015
Last verified: April 2015

October 12, 2006
April 15, 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 Archive Site
Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures
Same as current
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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.
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Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: denagliptin (GW823093)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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)
Contact information is only displayed when the study is recruiting subjects
United States
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Study Director: GSK Clinical Trial, DM, FRCP GlaxoSmithKline
April 2015

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