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GW823093C For The Treatment Of Type 2 Diabetes Mellitus

This study has been terminated.
(Safety issue)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370942
First Posted: September 1, 2006
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
August 30, 2006
September 1, 2006
March 24, 2017
April 2006
November 2006   (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
GW823093 Japan Phase IIa Mono
This study was designed to find dose response and as extension in treatment of GW823093C.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
159
November 2006
November 2006   (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
Sexes Eligible for Study: All
20 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00370942
DPB106652
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2017

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