The effect of metformin on blood glucose control in patients with type I diabetes
| ISRCTN | ISRCTN55324082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55324082 |
| Secondary identifying numbers | N0301111201 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 11/01/2010
- 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 Abu Ahmed
Scientific
Scientific
Diabetes Consultant
Blackpool, Fylde and Wyre Hospitals NHS Trust
Blackpool
FY3 8NR
United Kingdom
| Phone | +44 (0)1253 306723 |
|---|---|
| Abuahmeduk@yahoo.co.uk |
Study information
| Study design | Randomised double-blind cross-over controlled trial |
|---|---|
| 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 effect of metformin on diabetes control in insulin dependent diabetes mellitus (IDDM) |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Diabetes |
| Intervention | Metformin or placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | metformin |
| Primary outcome measure | Assessment of HbA1c and changes in fasting blood glucose during the study period |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2002 |
| Completion date | 30/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key inclusion criteria | 20 patients from the district diabetes register with body mass index (BMI) >27 with insulin-dependent diabetes mellitus (IDDM) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 30/05/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Diabetes Consultant
Blackpool
FY3 8NR
United Kingdom
FY3 8NR
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Blackpool Fylde & Wyre Hospitals NHS Trust (UK)
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 | 01/10/2006 | Yes | No |
