A randomized, double blind, placebo-controlled trial on the effect of rosiglitazone in reversing newly diagnosed type 2 diabetes to non-diabetic status

Completed

• Conditions: Diabetes mellitus (type 2); Urological and Genital Diseases

• Registration Number: ISRCTN76036162
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Type 2 diabetic patients above 18 years of age
2. Newly diagnosed diabetes within one year with HbA1c <7% at the time of entry to the study
3. No history of exposure to any anti-diabetic medications except diet control or insulin during period of gestational diabetes
4. Alcohol consumption less than 50 g/day

Exclusion Criteria

1. Significantly impaired renal function with plasma creatinine >200 mmol/l
2. Known case of liver cirrhosis (Child’s B grading or above) or significantly impaired liver function (alanine aminotransferase [ALT] or aspartate aminotransferase [AST], greater than two times the upper limit of normal)
3. Congestive heart failure of class III or IV by the New York Heart Association classification (NYHA)
4. Progressive fatal disease
5. History of drug or alcohol abuse
6. History of hypersensitivity to study medication or drugs with similar chemical structure to rosiglitazone
7. Pregnant women or those planning a pregnancy
8. Lactation
9. Known severe non-compliance to medication or any factor, which will affect the completion of the study as judged by the investigator
10. Need of any medication, which will affect interpretation of Oral Glucose Tolerance Test (OGTT) such as regular oral steroid or episodic high dose steroid

Study & Design

• Study Type: Interventional
• Study Design: Not specified