Metformin and sitagliptin in patients with impaired glucose tolerance and a recent TIA or minor ischemic stroke: A multicenter, randomized, open-label phase II trial.
Completed
- Conditions
- Stroke, transient ischemic attack, impaired glucose tolerance.Herseninfarct, TIA, gestoorde glucose tolerantie.
- Registration Number
- NL-OMON25556
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. 18 years or older;
2. Clinical diagnosis of TIA, amaurosis fugax or minor ischemic stroke within the previous 6 months;
Exclusion Criteria
1. Diabetes mellitus;
2. History of diabetic ketoacidosis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Baseline adjusted difference in 2-hour post-load glucose levels at 6 months
- Secondary Outcome Measures
Name Time Method 1.Baseline adjusted difference in fasting glucose levels at 6 months<br>2.Baseline adjusted difference in glycosylated hemoglobin 1c (HbA1c) levels at 6 months<br>3.Tolerability of metformin and sitagliptin assessed as number of patients still on treatment after 6 months;<br>4.Safety of treatment with metformin and sitagliptin assessed as percentage of (serious) adverse events in the treatment groups at 6 months;<br>5.Percentage of patien2ts with a normal glucose tolerance at 6 months.