Geriatric outcomes among older Type 2 diabetic patients treated with DPP4 inhibitors or glinides: focus on cognitive functioning (GOOD-WP3) - GOOD-WP3

A.O.U. Università degli Studi della Campania Luigi Vanvitelli0 个研究点目标入组 146 人开始时间: 2021年5月24日最近更新: 2021年8月17日

适应症

试验速览

暂无简介。

•diagnosis of type 2 diabetes prior to informed consent; male and female patients who are pre-treated with an unchanged dose of metformin almost 4 weeks prior to randomization visit. Dose for metformin is defined as the maximum tolerated dose; age = 70 years; HbA1c =7.5%; risk of sarcopenia: low handgrip (men = 30.0 kg, women = 20.0 kg) or slow habitual walking speed (< 1m/s);
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•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 146

•diagnosis of type 1 diabetes mellitus; impaired kidney function (eGFR<30 ml/min per 1.73 m2); active malignancy within 24 months prior to screening; heart failure NYHA III-IV; use of GLP-1 agonists or DPP-IV therapy in the last 3 months.
•history of pancreatitis; hepatic disease (liver function tests more than 3 times the upper limit of normal); chronic Obstructive Pulmonary Disease (COPD); uncontrolled hypertension (BP > 160/100 mm of Hg); known hypersensitivity to linagliptin and/or repaglinide or inactive ingredients; life expectancy less than 6 months; diagnosis of dementia; complete dependency in Basic Activities of Daily Living (BADL); participation in any other clinical trial; patients unwilling to provide consent and those who cannot be followed-up or unable to co-operate with the study procedures; treatment with anti-obesity drugs, systemic corticosteroids or nonsteroidal anti-inflammatory drugs, any other anti-diabetic medication including insulin therapy (except metformin).

发起方

A.O.U. Università degli Studi della Campania Luigi Vanvitelli