A Study Of BRL49653C For The Treatment Of Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00523913
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study Completion: 2007-04
• Study First Submitted: 2007-08-31
• Study First Submitted QC: 2007-08-31
• Study First Posted: 2007-09-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site