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

August 30, 2006
April 11, 2013
April 2006
February 2007   (final data collection date for primary outcome measure)
Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group [ Time Frame: 12 weeks ]
Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group
Complete list of historical versions of study NCT00370942 on ClinicalTrials.gov Archive Site
Long term safety variables [ Time Frame: 64 weeks ]
Long term safety variables
Not Provided
Not Provided
 
GW823093C For The Treatment Of Type 2 Diabetes Mellitus
Clinical Evaluation of GW823093C in Patients With Type 2 Diabetes Mellitus -Double-Blind Dose Finding and the Extension Study- <Phase 2 Study>

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: GW823093C A
    A=45 mg
  • Drug: GW823093C B
    B=30 mg
  • Drug: GW823093C C
    C=25 mg
  • Placebo Comparator: GW823093C A
    A=45 mg
    Intervention: Drug: GW823093C A
  • Placebo Comparator: GW823093C B
    B=30 mg
    Intervention: Drug: GW823093C B
  • Placebo Comparator: GW823093C C
    C=15 mg
    Intervention: Drug: GW823093C C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
October 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00370942
DPB106652
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP