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LIMIT: Lowering the Incidence of vascular complications with Metformin in patients with Impaired glucose tolerance and a recent TIA or minor ischemic stroke: a phase 2, randomized, controlled trial - LIMIT phase 2

LIMIT: Lowering the Incidence of vascular complications with Metformin in patients with Impaired glucose tolerance and a recent TIA or minor ischemic stroke: a phase 2, randomized, controlled trial - LIMIT phase 2

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-005772-41-NL
Enrollment
40
Registered
2006-10-20
Start date
2006-12-05
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with impaired glucose tolerance and a recent TIA or minor ischemic stroke MedDRA version: 8.1 Level: LLT Classification code 10052426 Term: Glucose intolerance

Interventions

Trade Name: metformin Pharmaceutical Form: Tablet INN or Proposed INN: METFORMIN CAS Number: 657249 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2000- Pharmaceut

Sponsors

investigator-driven research: Erasmus MC, Neurovascular Section
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Age > 18 years -TIA/minor ischemic stroke =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Diabetes mellitus -Dependency of others (mRankin = 4) -Contraindication metformin (severe renal failure, severe hepatic insufficiency, severe heart failure, severe hypoxic lung disease, lactic acidosis in history) -Severe comorbidity interfering with follow-up -Pregnancy or breast feading

Design outcomes

Primary

MeasureTime frame
Main Objective: The general aim of this study is to examine the tolerability and effectiveness of metformin treatment in patients with a recent TIA or minor ischemic stroke and impaired glucose tolerance. Primary outcomes will be the tolerability of metformin treatment (measured as number of patients still on treatment after 3 months), the safety of metformin treatment (which will be continuously monitored) and the adjusted difference in 2-hour post-load glucose levels at 3 months. ;Secondary Objective: Secondary outcomes will be the difference in fasting glucose levels, insulin resistance, body mass index, and percentage of patients with a normal glucose tolerance at 3 months.;Primary end point(s): Primary outcomes will be the tolerability of metformin treatment (measured as number of patients still on treatment after 3 months), the safety of metformin treatment (which will be continuously monitored) and the adjusted difference in 2-hour post-load glucose levels at 3 months.—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026