Condition category
Circulatory System
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
20/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.erasmusmc.nl/

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

Publication citations

Additional files

Editorial Notes