IMIT: 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

• Conditions: Patients with impaired glucose tolerance and a recent TIA or minor ischemic stroke; MedDRA version: 8.1Level: LLTClassification code 10052426Term: Glucose intolerance

• Registration Number: EUCTR2006-005772-41-NL
• Lead Sponsor: investigator-driven research: Erasmus MC, Neurovascular Section

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

-Age > 18 years
-TIA/minor ischemic stroke < 6 months
-Non-diabetics with impaired glucose tolerance (2hr post-load glucose 7.8-11.0 mmol/L) or impaired fasting glucose (fasting glucose 5.6-6.9 mmol/L)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.