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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00387972
First received: October 12, 2006
Last updated: November 8, 2006
Last verified: November 2006
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 450
Study Start Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387972

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

No publications provided

ClinicalTrials.gov Identifier: NCT00387972     History of Changes
Other Study ID Numbers: DPB107246
Study First Received: October 12, 2006
Last Updated: November 8, 2006
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 17, 2013