Diabetes mellitus (type 2) Urological and Genital Diseases Diabetes mellitus (type 2)
Conditions
Interventions
Primary intervention: rosiglitazone versus placebo for 52 weeks
Secondary intervention: standard lifestyle modification advice
Sponsors
Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycaemic status as assessed by 75 g OGTT at 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change of insulin resistance and insulin reserve as assessed by Homeostasis Model Assessment (HOMA) at 52 weeks 2. Cardiovascular risk factors assessed at 52 weeks 3. Treatment effect 13 weeks after treatment stopped | — |
Countries
Hong Kong
Outcome results
None listed