The effect of metformin on blood glucose control in patients with type I diabetes
| ISRCTN | ISRCTN55324082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55324082 |
| Protocol serial number | N0301111201 |
| Sponsor | Department of Health (UK) |
| Funder | Blackpool Fylde & Wyre Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind cross-over controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | metformin |
| Primary outcome measure(s) |
Assessment of HbA1c and changes in fasting blood glucose during the study period |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Diabetes Consultant
Blackpool
FY3 8NR
United Kingdom
FY3 8NR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
