LIMIT-1: Lowering the Incidence of vascular complications with Metformin in patients with Impaired glucose Tolerance and a recent transient ischaemic attack or minor ischaemic stroke: a phase II randomised, controlled trial

ISRCTN ISRCTN54960762
DOI https://doi.org/10.1186/ISRCTN54960762
Secondary identifying numbers N/A
Submission date
11/04/2007
Registration date
11/04/2007
Last edited
20/03/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Esther van der Heijden
Scientific

Stroke Research Assistant
Erasmus Medical Centre
Room Ee 22.42
P.O. Box 1738
Rotterdam
3000 DR
Netherlands

Phone +31 (0)10 408 7818
Email stroke-research@erasmusmc.nl

Study information

Study designRandomised, open-label, multicentre, controlled, parallel group trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymLIMIT-1
Study objectivesMetformin will be tolerated in patients with Transient Ischaemic Attack (TIA) or minor ischaemic stroke and will result in blood glucose lowering.
Ethics approval(s)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]).
Health condition(s) or problem(s) studiedTransient ischaemic attack or minor ischaemic stroke
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Metformin
Primary outcome measure1. 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 measures1. 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 study start date01/02/2007
Completion date01/02/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/02/2007
Date of final enrolment01/02/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Stroke Research Assistant
Rotterdam
3000 DR
Netherlands

Sponsor information

Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre

Department of Neurology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Website http://www.erasmusmc.nl/
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Hospital/treatment centre

Erasmus Medical Centre (The Netherlands)

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