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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014