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
  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:


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
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: 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 October 19, 2014