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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.


- candidate number10698
- NTR NumberNTR3196
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-dec-2011
- Secondary IDsMAAS Erasmus Medical Center
- Public TitleMetformin and sitagliptin in patients with impaired glucose tolerance and a recent TIA or minor ischemic stroke: A multicenter, randomized, open-label phase II trial.
- Scientific TitleMetformin and sitagliptin in patients with impaired glucose tolerance and a recent TIA or minor ischemic stroke: A multicenter, randomized, open-label phase II trial.
- ACRONYMMAAS trial
- hypothesisWe aim to compare the effectiveness, feasibility and safety of both metformin and sitagliptin in patients with TIA or minor ischemic stroke and impaired glucose tolerance. We will assess whether a slow increase in dose of metformin and better support and information on this treatment will reduce the incidence of side effects in these patients, and whether it will improve treatment compliance.
- Healt Condition(s) or Problem(s) studiedGlucose intolerance, Ischemic stroke, TIA
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2012
- planned closingdate31-dec-2012
- Target number of participants100
- InterventionsPatients 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, which will be slowly increased in 6-weeks time to a daily dose of two times 1000 mg. Patients allocated to sitagliptin will be treated with a daily dose of 100 mg.
- Primary outcome1. Tolerability of metformin and sitagliptin assessed as number of patients still on treatment after 6 months;
2. Safety of treatment with metformin and sitagliptin assessed as percentage of (serious) adverse events in the treatment groups at 3 months and at 6 months;
3. Baseline adjusted difference in 2-hour post-load glucose levels at 6 months.
- Secondary outcome1. Baseline adjusted differences in 2-hour post-load glucose levels at 3 months;
2. Fasting glucose levels at 3 and 6 months;
3. Body mass index (BMI) at 6 months;
4. Waist circumference at 6 months;
5. Percentage of patients with a normal glucose tolerance at 6 months.
- Timepoints3 months and 6 months, see also primary and secondary outcomes.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. Susanne Fonville
- CONTACT for SCIENTIFIC QUERIESDrs. Susanne Fonville
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryRationale:
Impaired glucose tolerance (defined as a 2-hour post load glucose level 7.8-11.0 mmol/L) is present in one third of the patients with a TIA or ischemic stroke, and is associated with a two-fold risk of recurrent stroke. Intensive glucose control with oral antidiabetic drugs have been shown to reduce the rate of progression to diabetes type II in patients with impaired glucose tolerance. Our recent study suggests that the widely used oral glucose-lowering drug metformin is safe and improves glucose tolerance in patients with TIA or minor ischemic stroke and impaired glucose tolerance, but often leads to gastro-intestinal side effects resulting in permanent discontinuation. The novel antidiabetic drug sitagliptin seems equally effective with fewer side effects in patients with impaired glucose tolerance.

Objective:
We aim to compare the effectiveness, feasibility and safety of both metformin and sitagliptin in patients with TIA or minor ischemic stroke and impaired glucose tolerance. We will assess whether a slow increase in dose of metformin and better support and information on this treatment will reduce the incidence of side effects in these patients, and whether it will improve treatment compliance.

Study design:
Phase 2, multicenter, randomized, controlled, open-label trial with blinded outcome assessment.

Study population:
Patients 18 years or older with recent (<6 months) TIA or minor ischemic stroke (mRS≤3) and impaired glucose tolerance.

Intervention:
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, which will be slowly increased in 6-weeks time to a daily dose of two times 1000 mg. Patients allocated to sitagliptin will be treated with a daily dose of 100 mg.

Main study parameters/endpoints:
Percentage still on treatment, percentage of (serious) adverse events in the treatment groups, baseline adjusted fasting glucose, 2-hour post-load glucose levels, BMI and waist circumference at 3 and 6 months, and the percentage of patients with normal glucose tolerance at 6 months.
- Main changes (audit trail)
- RECORD15-dec-2011 - 23-dec-2011


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