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

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: Rosiglitazone 4 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Rosiglitazone
  • 4mg
• Placebo Comparator: Rosiglitazone placebo
  • 4mg

Primary Measures

• glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin)
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• 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
  • Time Frame: 8, 16, and 24 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00349427

Study ID Number: AVD102209

ClinicalTrials.gov Identifier: NCT00349427

Health Authority: China: State Food and Drug Administration