Metformin and sitagliptin in patients with impaired glucose tolerance and a recent TIA or minor ischemic stroke - safety and feasibility

Phase 2

Recruiting

Conditions: impaired glucose tolerance
stroke
10018424
10007963

Registration Number: NL-OMON44685

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- 18 years or older
- clinical diagnosis of TIA, amaurosis fugax or minor ischemic stroke within the previous 6 months
- impaired glucose tolerance (2-hour post-load glucose level 7.8-11.0mmol/L)

Exclusion Criteria

- diabetes mellitus
- history of diabetic ketoacidosis
- symptoms of type 1 diabetes mellitus
- signs of renal impairment (creatinin of 135 µmol/L or higher for men, and 110 µmol/L or higher for women)
- known liver disease or disturbed liver function tests (alanine amino transferase, aspartate amino transferase, alkaline phosphatase, or γ glutamyl transferase increased to more than twice the upper limit of typical values)
- history of lactic acidosis
- heart failure requiring pharmacological therapy
- pancreatitis
- chronic hypoxic lung disease
- use of digoxin
- pregnancy
- breast feeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes will be the tolerability of metformin and sitagliptin<br /><br>(assessed as number of patients still on treatment after 6 months), the safety<br /><br>of treatment with metformin and sitagliptin, and the baseline adjusted<br /><br>difference in 2-hour post-load glucose levels at 6 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will include baseline adjusted differences in 2-hour<br /><br>post-load glucose levels at 6 months, fasting glucose levels at 6 months, body<br /><br>mass index (BMI), waist circumference and percentage of patients with a normal<br /><br>glucose tolerance at 6 months.<br /><br><br /><br>In addition, the percentage of patients with diabetes mellitus type II (defined<br /><br>as fasting glucose levels higher than 7.0 mmol/L measured on 2 different days,<br /><br>or random serum glucose levels higher than 11.0 mmol/L with complaints of<br /><br>hyperglycemia, or use of oral or parenteral anti-diabetic medication) at 5<br /><br>years and the incidence of TIA, stroke, coronary artery disease and peripheral<br /><br>artery disease at 5 years</p><br>