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

ISRCTN	ISRCTN76036162
DOI	https://doi.org/10.1186/ISRCTN76036162
Protocol serial number	N/A
Sponsor	Chinese University of Hong Kong
Funders	Chinese University of Hong Kong, (investigator-initiated study)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Francis C.C. Chow
Scientific

Flat 8A
Block B
Staff Quarters
Prince of Wales Hospital
Shatin, New Territories
-
Hong Kong

Primary study design	Interventional
Study design	Randomized, double-blind, placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Rosiglitazone will be effective in reversing newly diagnosed mild diabetes to non-diabetic status
Ethics approval(s)	Study protocol, informed consent documents, any addenda or amendments have been reviewed and approved jointly by the Chinese University of Hong Kong, New Territories and the East Cluster Clinical Research Ethics Committee, reference number CRE-2003.111-T
Health condition(s) or problem(s) studied	Diabetes mellitus (type 2)
Intervention	Primary intervention: rosiglitazone versus placebo for 52 weeks Secondary intervention: standard lifestyle modification advice
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Rosiglitazone
Primary outcome measure(s)	Glycaemic status as assessed by 75 g OGTT at 52 weeks
Key secondary outcome measure(s)	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
Completion date	25/01/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	09/09/2003
Date of final enrolment	25/01/2006

Flat 8A

Shatin, New Territories
-
Hong Kong

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan