The relationship between genetic polymorphisms in the organic cation transporter genes and the pharmacokinetics and pharmacodynamics of metformin - The genetics of metformin excretion

The University of Liverpool0 个研究点目标入组 200 人开始时间: 2005年5月4日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•1. Subject is aged between 25 and 85 years of age inclusive.
•2. Subject has given signed informed consent (written and witnessed).
•3. Subject has a diagnosis of type 2 diabetes mellitus, regardless of how and when that diagnosis was established.
•4. Subject’s anti-hyperglycaemic medication consists of metformin monotherapy, at a dosage of 500mg three times daily and that dosage has been established for a period of at least 3 months.
•5. Subject has not missed any metformin doses for a period of at least 5 days and compliance has been assessed through a validated compliance questionnaire.
•6. Subject is able to recall at least approximate timing of dosing (within 30 minutes).
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Subject is, in the opinion of the Investigator, not suitable to participate in the study.
•2. Subject has a diagnosis of pernicious anaemia.
•3. Subject is also prescribed additional anti-hyperglycaemic medication such as sulphonylureas, meglitinide analogues, thiazolidinediones or insulin.
•4. Subject has taken any known inhibitor of OCT1 or OCT2, such as amantadine, cimetidine, clonidine, desipramine, midazolam, procainamide, quinidine, quinine, or verapamil in the last 4 weeks.
•5. Subject has participated in strenuous physical activity, defined as more than typical walking pace, for a period of 8 hours prior to study entry.
•6. Subject has an alcohol intake greater than the recommended weekly safe drinking limits (>21 units in men; >14 units in women).

发起方

The University of Liverpool