A Study Of Rosiglitazone Plus Insulin To Treat Type 2 Diabetes Mellitus Patients

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
• Interventions: Drug: Rosiglitazone 4 mg

• Registration Number: NCT00349427
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type 2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone is efficacious in terms of improving glycemic control.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-07-06
• Study First Submitted QC: 2006-07-06
• Study First Posted: 2006-07-07
• Status Verified: 2011-02
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosiglitazone	Rosiglitazone 4 mg	4mg
Rosiglitazone placebo	Rosiglitazone 4 mg	4mg

Primary Outcome Measures

Name	Time	Method
glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin)	24 weeks

Secondary Outcome Measures

Name	Time	Method
glycemic control at treatment 24-week measured by fasting plasma glucose and daily insulin dose, proportion of subjects who reduce total daily insulin dose after treatment of 8, 16, and 24 weeks	8, 16, and 24 weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Tianjin, China