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

Conditions: StrokeTransient ischemic attackImpaired glucose tolerance
MedDRA version: 14.1Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1Level: LLTClassification code 10052426Term: Glucose intoleranceSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 14.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
MedDRA version: 14.1Level: LLTClassification code 10044391Term: Transient ischemic attacksSystem Organ Class: 10029205 - Nervous system disorders

Registration Number: EUCTR2011-005980-26-NL

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.