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A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study

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.
ClinicalTrials.gov Identifier: NCT00432679
Recruitment Status : Completed
First Posted : February 8, 2007
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Rosiglitazone (BRL49653C) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Combination Therapy With Sulfonyl Urea) - A Placebo-Controlled Double-Blind Study -
Study Start Date : May 2006
Primary Completion Date : March 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: arm 1
study drug
Drug: Rosiglitazone (BRL49653C)
study drug


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in HbA1c after 16 weeks of treatment in rosiglitazone group and placebo group [ Time Frame: 16 Weeks ]

Secondary Outcome Measures :
  1. Change from baseline after 16 weeks of treatment in FPG; fasting insulin, fasting proinsulin, HOMA-IR and HOMA-; adiponectin, leptin and hs-CRP Proportion of cases with changes in HbA1c and FPG meeting specified criteria after 16 weeks of treatment [ Time Frame: 16 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.

Exclusion criteria:

  • Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432679


Locations
Japan
GSK Investigational Site
Kumamoto, Japan, 862-0976
GSK Investigational Site
Oita, Japan, 870-0039
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Additional Information:
Publications:
This study has not been published in the scientific literature.

Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: AVD105248
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: AVD105248
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: AVD105248
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: AVD105248
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: AVD105248
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: AVD105248
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: AVD105248
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00432679     History of Changes
Other Study ID Numbers: AVD105248
First Posted: February 8, 2007    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
rosiglitazone
Avandia
type 2 diabetes mellitus
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs