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

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

Study information

Study designRandomized open-labelled comparing two standard therapies
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedType 2 diabetic patients with conventional OAD failure
InterventionAdd-on with either rosigitazone or nocte insulin
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Rosiglitazone, insulin
Primary outcome measureGlycaemic improvement
Secondary outcome measures1. Lipid and blood pressure (BP) changes
2. Tolerability
Overall study start date10/01/2000
Completion date31/12/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants110
Key inclusion criteriaChinese type 2 diabetic patients with conventional OAD failure
Key exclusion criteriaType 1 diabetes
Date of first enrolment10/01/2000
Date of final enrolment31/12/2001

Locations

Countries of recruitment

  • Hong Kong

Study participating centre

Block J
New Territories
-
Hong Kong

Sponsor information

AH Nethersole Hospital, Department Research Fund (Hong Kong)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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