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 - MAAS trial

未提供0 个研究点开始时间: 2012年2月13日最近更新: 2012年7月10日

试验速览

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•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

•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.

发起方

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