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Trial History Detail on 2012-08-31

CUHK_CCT00095

2006-03-28

Retrospective

Chinese University of Hong Kong (investigator-initiated study) GlaxoSmithKline Limited

Dr Francis C.C. Chow

Dr Wing Bun Chan Dr Wing Yee So Dr Ronald C.W. Ma Dr Risa Ozaki Dr C.S. Cockram Dr H.K. Pang Dr I.M. Wong

Lana Lam

Telephone, Telephone:26323221,Fax, Fax:26492397,

email. email:wbchan@cuhk.edu.hk

Dr Wing Bun Chan

Telephone, Telephone:26323221,Fax, Fax:26492397,

email email:wbchan@cuhk.edu.hk

A Randomized, Double Blind, Placebo Controlled Trial on the Effect of Rosiglitazone in Reversion of Newly Diagnosed Type 2 Diabetes to Non-Diabetic Status

DM Reversion Trial

Yes

2003-04-23

Diabetes Mellitus

Drug

Primary intervention: Rosiglitasone or Placebo for 52 weeks. Secondary intervention: Standard advice on lifestyle modification.

52 weeks

Matching placebo tablets

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 1. Significantly impaired renal function with plasma creatinine > 200ƒÝmol/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.

Randomized

Placebo

Double-blind

Parallel

2003-09-09

80

Complete

Glycaemic status assessed by 75g OGTT at 52 weeks.

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.

No

2006-03-28

ChiCTR-TRC-09000683

2010-05-04


Yes

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