Contact information
Type
Scientific
Primary contact
Ms Esther van der Heijden
ORCID ID
Contact details
Stroke Research Assistant
Erasmus Medical Centre
Room Ee 22.42
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 408 7818
stroke-research@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
LIMIT-1
Study hypothesis
Metformin will be tolerated in patients with Transient Ischaemic Attack (TIA) or minor ischaemic stroke and will result in blood glucose lowering.
Ethics approval
Received from the Medical Ethics Committee of Erasmus Medical Centre on the 5th December 2006 (ref: NL15011.078.06 [local METC number MEC-2006-303]).
Study design
Randomised, open-label, multicentre, controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Transient ischaemic attack or minor ischaemic stroke
Intervention
Patients will be randomised for metformin or no oral anti-diabetic drug (open-label) on top of optimal standard treatment, including lifestyle advice aimed at weight reduction and regular physical exercise.
Patients allocated to metformin will be treated with metformin for three months from the day of randomisation until study end. They will start with a daily dose of 500 mg that will be slowly increased in one-month time to a daily dose of 2,000 mg in two gifts. All patients will be followed for three months.
Intervention type
Drug
Phase
Phase II
Drug names
Metformin
Primary outcome measures
1. Tolerability of metformin treatment (measured as number of patients still on treatment after three months)
2. The safety of metformin treatment (which will be continuously monitored)
3. The adjusted difference in two-hour post-load glucose levels at three months
Primary outcomes will be measured at three months for feasability (safety will be continuously monitored). Primary outcome on effect on post-load glucose level will be measured at three months, expressed as a for baseline adjusted difference in mean two-hour post-load glucose levels at three months between treatment groups.
Secondary outcome measures
1. Differences in fasting glucose levels
2. Insulin resistance
3. Body mass index
4. Percentage of patients with a normal glucose tolerance at three months
Secondary outcomes will be measured at three months, as a for baseline adjusted difference between groups.
Overall trial start date
01/02/2007
Overall trial end date
01/02/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men or women 18 years and over
2. TIA/minor ischaemic stroke (modified Rankin Score three or less) within six months
3. Impaired fasting glucose (fasting glucose level of 5.6 to 6.9 mmol/L) and/or impaired glucose tolerance (two-hour post-load glucose level of 7.8 to 11.0 mmol/L)
4. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Known or newly diagnosed diabetes mellitus
2. Contraindication for metformin:
2.1. Renal impairment (serum creatinine greater than 135 micromol/L for men, and greater than 110 micromol/L for women)
2.2. Hepatic disease (liver enzymes increased twice the upper limit of normal)
2.3. A past history of lactic acidosis
2.4. Cardiac failure requiring pharmacological therapy
2.5. Chronic hypoxic lung disease
2.6. Pregnancy
2.7. Breast feeding
3. Severe comorbidity interfering with follow-up
Recruitment start date
01/02/2007
Recruitment end date
01/02/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Stroke Research Assistant
Rotterdam
3000 DR
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
Department of Neurology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Centre (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary