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

A Randomized, Double-Blind, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone Compared to Insulin Plus Placebo for 24 Weeks in Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin

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.

Inclusion:

• Patients with type 2 Diabetes mellitus on a minimum dose of 30 units/day insulin monotherapy continuously for at least 8 weeks
• If Patients are taking another oral antidiabetic agent may stop their oral agent and adjust their insulin dose properly over 8 weeks prior to screening if they are asked by doctor who considers him/her suitable for study in all other respects, and the HbA1c level>7.5%.

Exclusion:

• Fasting plasma glucose >13 mmol/L at screening
• Ongoing edema or history of peripheral edema requiring pharmacological treatment within 12 months
• Drug abuse
• Women pregnant or lactating
• Use any rosiglitazone like drug in 3 months
• Use more than one oral antidiabetic agent in 2 months
• Uncontrolled hypertension
• Chronic heart failure
• Anemia