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GW823093C For The Treatment Of Type 2 Diabetes Mellitus

This study has been terminated.
(Safety issue)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00370942
First received: August 30, 2006
Last updated: April 11, 2013
Last verified: July 2012
History of Changes
  Purpose

This study was designed to find dose response and as extension in treatment of GW823093C.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: GW823093C A
Drug: GW823093C B
Drug: GW823093C C
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of GW823093C in Patients With Type 2 Diabetes Mellitus -Double-Blind Dose Finding and the Extension Study- <Phase 2 Study>

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Long term safety variables [ Time Frame: 64 weeks ]

Enrollment: 200
Study Start Date: April 2006
Study Completion Date: October 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: GW823093C A
A=45 mg
 Drug: GW823093C A
A=45 mg
Placebo Comparator: GW823093C B
B=30 mg
 Drug: GW823093C B
B=30 mg
Placebo Comparator: GW823093C C
C=15 mg
 Drug: GW823093C C
C=25 mg

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Type 2 diabetes mellitus.
  • Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones))

Exclusion criteria:

  • Patients who have metabolic disease judged by investigator as a clinically significance
  • Serious cardiovascular disease or serious hepatic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370942

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00370942     History of Changes
Other Study ID Numbers: DPB106652
Study First Received: August 30, 2006
Last Updated: April 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
GW823093C
diabetes
type 2 diabetes mellitus
DPP-IV inhibitor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013