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A Study Of BRL49653C For The Treatment Of Type 2 Diabetes

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: August 31, 2007
Last updated: October 1, 2010
Last verified: October 2010
This study is designed to evaluate the safety of BRL49653C administrated for 52 weeks

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: rosiglitazone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus -Long-term Study of Rosiglitazone Maleate-

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The safety profile (adverse events, laboratory parameters and other observations) of BRL49653C administered for 52 weeks will be evaluated. [ Time Frame: 52 Weeks ]

Secondary Outcome Measures:
  • The efficacy profile (HbA1c, FPG and Insulin) of BRL49653C administered for 52 weeks will be evaluated. [ Time Frame: 52 Weeks ]

Enrollment: 70
Study Start Date: November 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- Patients with type 2 diabetes mellitus managed by diet therapy or one antidiabetic agent (sulfonylurea or alpha glucosidase inhibitor) will be candidates 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
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 identifier: NCT00523913

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

Responsible Party: Study Director, GSK Identifier: NCT00523913     History of Changes
Other Study ID Numbers: AVD105720 
Study First Received: August 31, 2007
Last Updated: October 1, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by GlaxoSmithKline:
type 2 diabetes mellitus;

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 30, 2016