Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/03/2006
Date assigned
25/04/2006
Last edited
24/09/2009
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 Gary Tin-Choi Ko

ORCID ID

Contact details

Block J
6th Floor
AH Nethersole Hospital
Department of Medicine
Tai Po
New Territories
-
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the efficacy and tolerability of rosiglitazone in the treatment of secondary oral anti-diabetic drug (OAD) failure and its direct comparisons against bedtime insulin

Ethics approval

Approved by the AH Nethersole Hospital Ethics Committee, December 1999

Study design

Randomized open-labelled comparing two standard therapies

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Type 2 diabetic patients with conventional OAD failure

Intervention

Add-on with either rosigitazone or nocte insulin

Intervention type

Drug

Phase

Not Specified

Drug names

Rosiglitazone, insulin

Primary outcome measures

Glycaemic improvement

Secondary outcome measures

1. Lipid and blood pressure (BP) changes
2. Tolerability

Overall trial start date

10/01/2000

Overall trial end date

31/12/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Chinese type 2 diabetic patients with conventional OAD failure

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

110

Participant exclusion criteria

Type 1 diabetes

Recruitment start date

10/01/2000

Recruitment end date

31/12/2001

Locations

Countries of recruitment

Hong Kong

Trial participating centre

Block J
New Territories
-
Hong Kong

Sponsor information

Organisation

AH Nethersole Hospital, Department Research Fund (Hong Kong)

Sponsor details

Block J
6th Floor
AH Nethersole Hospital
Department of Medicine
Tai Po
New Territories
-
Hong Kong

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Self-funded - Departmental Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

AH Nethersole Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Medicine

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17142216

Publication citations

  1. Results

    Ko GT, Tsang PC, Wai HP, Kan EC, Chan HC, Rosiglitazone versus bedtime insulin in the treatment of patients with conventional oral antidiabetic drug failure: a 1-year randomized clinical trial., Adv Ther, 23, 5, 799-808.

Additional files

Editorial Notes