Diabetes Mellitus
Conditions
Interventions
Two groups:Primary intervention: Rosiglitasone or Placebo for 52 weeks. Secondary intervention: Standard advice on lifestyle modification for 52 weeks versus placebo
Sponsors
Dr Francis C.C. Chow
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetic patients above 18 years of age; 2. Newly diagnosed diabetes within one year with HbA1c less than or equals 7.0% at time of study entry; 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 50g/day.
Exclusion criteria
Exclusion criteria: 1. Significantly impaired renal function with plasma creatinine > 200 mol/l; 2. Known case of cirrhosis (Child's B grading or above) or significant impaired liver function (ALT or AST greater than 2 times upper limit of normal); 3. Congestive heart failure of class III or IV 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; 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 judge by the investigator; 10. Need of any medication which will affect the interpretation of OGTT such as regular oral steroid or episodic high dose steroid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycaemic status assessed by 75g OGTT at 52 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change of insulin resistance and insulin reserve assessed by HOMA model at 52 weeks. 2. Cardiovascular risk factors assessed at 52 weeks. 3. Treatment effect 13 weeks after treatment stopped.; | — |
Countries
China
Contacts
Public ContactDr Wing Bun Chan
Outcome results
None listed