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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387972
First Posted: October 13, 2006
Last Update Posted: April 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GlaxoSmithKline
  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
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387972


  Show 57 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trial, DM, FRCP GlaxoSmithKline
  More Information

ClinicalTrials.gov Identifier: NCT00387972     History of Changes
Other Study ID Numbers: DPB107246
First Submitted: October 12, 2006
First Posted: October 13, 2006
Last Update Posted: April 17, 2015
Last Verified: April 2015

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