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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Insulin; Insulin, Globin Zinc; Rosiglitazone

Criteria

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