Condition category
Urological and Genital Diseases
Date applied
11/01/2006
Date assigned
28/02/2006
Last edited
01/03/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francis C.C. Chow

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Rosiglitazone will be effective in reversing newly diagnosed mild diabetes to non-diabetic status

Ethics approval

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

Study design

Randomized, double-blind, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Rosiglitazone

Primary outcome measures

Glycaemic status as assessed by 75 g OGTT at 52 weeks

Secondary outcome measures

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

Overall trial start date

09/09/2003

Overall trial end date

25/01/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

09/09/2003

Recruitment end date

25/01/2006

Locations

Countries of recruitment

Hong Kong

Trial participating centre

Flat 8A
Shatin, New Territories
-
Hong Kong

Sponsor information

Organisation

Chinese University of Hong Kong

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Chinese University of Hong Kong

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

(investigator-initiated study)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes