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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25556

Enrollment

100

Registered

2011-12-15

Start date

2014-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, transient ischemic attack, impaired glucose tolerance. Herseninfarct, TIA, gestoorde glucose tolerantie.

Interventions

Patients will be randomized to receive either open-label metformin or sitagliptin or “no metformin” in a 1:1:2 ratio for 6 months. Patients allocated to metformin will start with 500 mg twice daily, w

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18 years or older; 2. Clinical diagnosis of TIA, amaurosis fugax or minor ischemic stroke within the previous 6 months; 3. Impaired glucose tolerance (2-hour post-load glucose level 7.8-11.0mmol/L).

Exclusion criteria

Exclusion criteria: 1. Diabetes mellitus; 2. History of diabetic ketoacidosis; 3. Symptoms of type 1 diabetes mellitus; 4. Signs of renal impairment (creatinin of 135 μmol/L or higher for men, and 110 μmol/L or higher for women); 5. 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); 6. History of lactic acidosis; 7. Heart failure requiring pharmacological therapy; 8. Pancreatitis; 9. Chronic hypoxic lung disease; 10. Use of digoxin; 11. Pregnancy; 12. Breast feeding.

Design outcomes

Primary

Measure	Time frame
1. Baseline adjusted difference in 2-hour post-load glucose levels at 6 months	—

Secondary

Measure	Time frame
1. Baseline adjusted difference in fasting glucose levels at 6 months 2. Baseline adjusted difference in glycosylated hemoglobin 1c (HbA1c) levels at 6 months 3. Tolerability of metformin and sitagliptin assessed as number of patients still on treatment after 6 months; 4. Safety of treatment with metformin and sitagliptin assessed as percentage of (serious) adverse events in the treatment groups at 6 months; 5. Percentage of patien2ts with a normal glucose tolerance at 6 months.	—

Measure

Time frame

1. Baseline adjusted difference in fasting glucose levels at 6 months 2. Baseline adjusted difference in glycosylated hemoglobin 1c (HbA1c) levels at 6 months 3. Tolerability of metformin and sitagliptin assessed as number of patients still on treatment after 6 months; 4. Safety of treatment with metformin and sitagliptin assessed as percentage of (serious) adverse events in the treatment groups at 6 months; 5. Percentage of patien2ts with a normal glucose tolerance at 6 months.

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Contacts

Public ContactElizabeth Osei

Flevoziekenhuis

l.osei.neurologie@gmail.com0368688720

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)