Stroke Transient ischemic attack Impaired glucose tolerance MedDRA version: 14.1 Level: LLT Classification code 10042244 Term: Stroke System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: LLT Classification code 10052426 Term: Glucose intolerance System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 10029205 - Nervous system disorders MedDRA versi
Conditions
Interventions
Product Name: metformin
Product Code: metformin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: METFORMIN
CAS Number: 657-24-9
Current Sponsor code: metformin
Product Name: sitagliptin
P
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible for inclusion if they are 18 years or older, have a clinical diagnosis of TIA, amaurosis fugax or minor ischemic stroke (defined as a modified Rankin scale (mRS) score of 3 or less) within the previous 6 months, and have impaired glucose tolerance, defined as 2-hour post-load glucose levels between 7.8 and 11.0 mmol/L. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: Patients will be excluded if they are known to have diabetes mellitus or a history of diabetic ketoacidosis, if they have 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 ? glutamyl transferase increased to more than twice the upper limit of typical values), a history of lactic acidosis, heart failure requiring pharmacological therapy, pancreatitis or chronic hypoxic lung disease, if they use digoxin or in case of pregnancy or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effectiveness, feasibility and safety of both metformin and sitagliptin in patients with TIA or minor ischemic stroke and impaired glucose tolerance.;Secondary Objective: To assess whether a slow increase in dose of metformin over a 6 week period and better support and information on this treatment will reduce the incidence of gastrointestinal side effects in these patients, and whether it will improve treatment compliance.;Timepoint(s) of evaluation of this end point: - the tolerability of metformin and sitagliptin: after 6 months. - the safety of treatment with metformin and sitagliptin: after 6 months. - the effect on 2-hour post-load glucose levels: at 6 months;Primary end point(s): Main study parameters: - the tolerability of metformin and sitagliptin, assessed as number of patients still on treatment after 6 months. - the safety of treatment with metformin and sitagliptin, assessed as number of adverse events and serious adverse events after 6 months. - the effect on 2-hour post-load glucose levels at 6 months, assessed as the baseline adjusted difference in 2-hour post-load glucose levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study parameters: - the effect on 2-hour post-load glucose levels at 3 months, assessed as the baseline adjusted difference in 2-hour post-load glucose levels - the effect on fasting glucose levels at 3 and 6 months, assessed as the baseline adjusted difference in fasting glucose levels - the effect on body mass index (BMI) and waist circumference at 6 months - the percentage of patients with a normal glucose tolerance at 6 months;Timepoint(s) of evaluation of this end point: - the effect on 2-hour post-load glucose levels: at 3 months - the effect on fasting glucose levels: at 3 and 6 months - the effect on body mass index (BMI) and waist circumference: at 6 months - the percentage of patients with a normal glucose tolerance: at 6 months | — |
Countries
Netherlands
Outcome results
None listed