The use of rosiglitazone or bedtime insulin in the treatment of conventional oral anti-diabetic drug failure: a one-year randomized clinical trial
ISRCTN | ISRCTN33022160 |
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DOI | https://doi.org/10.1186/ISRCTN33022160 |
Secondary identifying numbers | N/A |
- Submission date
- 28/03/2006
- Registration date
- 25/04/2006
- Last edited
- 24/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gary Tin-Choi Ko
Scientific
Scientific
Block J
6th Floor
AH Nethersole Hospital
Department of Medicine
Tai Po
New Territories
-
Hong Kong
Study information
Study design | Randomized open-labelled comparing two standard therapies |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | 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(s) | Approved by the AH Nethersole Hospital Ethics Committee, December 1999 |
Health condition(s) or problem(s) studied | Type 2 diabetic patients with conventional OAD failure |
Intervention | Add-on with either rosigitazone or nocte insulin |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Rosiglitazone, insulin |
Primary outcome measure | Glycaemic improvement |
Secondary outcome measures | 1. Lipid and blood pressure (BP) changes 2. Tolerability |
Overall study start date | 10/01/2000 |
Completion date | 31/12/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 110 |
Key inclusion criteria | Chinese type 2 diabetic patients with conventional OAD failure |
Key exclusion criteria | Type 1 diabetes |
Date of first enrolment | 10/01/2000 |
Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
Block J
New Territories
-
Hong Kong
-
Hong Kong
Sponsor information
AH Nethersole Hospital, Department Research Fund (Hong Kong)
Hospital/treatment centre
Hospital/treatment centre
Block J
6th Floor
AH Nethersole Hospital
Department of Medicine
Tai Po
New Territories
-
Hong Kong
Funders
Funder type
Hospital/treatment centre
Self-funded - Departmental Research Fund
No information available
AH Nethersole Hospital
No information available
Department of Medicine
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/09/2006 | Yes | No |