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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17142216
Publication citations
-
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.