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CompletedNCT00523913Updated Oct 28, 2016

A Study Of BRL49653C For The Treatment Of Type 2 Diabetes

A Phase 3 interventional study of rosiglitazone in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Completed at 1 site. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-10-28.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study summary

This study is designed to evaluate the safety of BRL49653C administrated for 52 weeks

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • type 2 diabetes mellitus;
  • diabetes;
  • rosiglitazone
  • Avandia;
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 70 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
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

Exclusion Criteria:

  • Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Interventions

  • Drugrosiglitazone
06

What researchers measure

Primary outcomes

  1. The safety profile (adverse events, laboratory parameters and other observations) of BRL49653C administered for 52 weeks will be evaluated.

    Time frame: 52 Weeks

Secondary outcomes

  1. The efficacy profile (HbA1c, FPG and Insulin) of BRL49653C administered for 52 weeks will be evaluated.

    Time frame: 52 Weeks

07

Study locations

1 site
  • GSK Investigational Site
08

References and documents

Publications

  • This study has not been published in the scientific literature.

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00523913
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 3, 2007
Start date
Nov 2005
Completion
Apr 2007
Last update
Oct 28, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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