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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Recruitment Status : Withdrawn (Study cancelled before enrollment)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:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: denagliptin (GW823093) Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : May 2006
Estimated Primary Completion Date : October 2007
Estimated Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in blood glucose regulation after 26 weeks of treatment

Secondary Outcome Measures :
  1. Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures

Eligibility Criteria

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


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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 Posted: October 13, 2006    Key Record Dates
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