E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with impaired glucose tolerance and a recent TIA or minor ischemic stroke |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052426 |
E.1.2 | Term | Glucose intolerance |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |