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 |
|---|---|
| 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 |
|---|---|
| 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 |
|---|---|
| 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 | |
|---|---|
| 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 |
