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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This study has been withdrawn prior to enrollment.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
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
Intervention Model: Parallel Assignment
Masking: Double
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

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

Enrollment: 0
Study Start Date: May 2006
Estimated Study Completion Date: October 2007
Estimated Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00387972

  Show 57 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trial, DM, FRCP GlaxoSmithKline
  More Information Identifier: NCT00387972     History of Changes
Other Study ID Numbers: DPB107246
Study First Received: October 12, 2006
Last Updated: April 15, 2015

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on September 21, 2017