ISRCTN54960762CompletedNot Applicable
IMIT-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
Erasmus Medical Centre (The Netherlands)0 sites40 target enrollmentStarted: April 11, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
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
Investigators
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