Geriatric outcomes among older Type 2 diabetic patients treated with DPP4 inhibitors or glinides: focus on sarcopenia markers of muscle and physical performance status (GOOD-WP2) - GOOD-WP2

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 180 人开始时间: 2021年2月10日最近更新: 2023年9月11日

适应症

试验速览

暂无简介。

•Diagnosis of type 2 diabetes mellitus; Pre-treated male and female patients with an unchenged metformin dose at least 4 weeks prior to randomization visit. The dose of metformin is defined as the maximun tolerated dose; age =70 years; HbA1c = 7.5%; risk of sarcopenia: low prehension strenght (men = 30.0 kg, women = 20.0 kg) or habitual slowness in walking speed (<1m/s); written informed consent signed and dated.
•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 180

•Diagnosis of type 1 diabetes mellitus; impaired renal 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 DPP4i 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 non-steroidal anti-inflammatory drugs, any other anti-diabetic medication including insulin therapy (except metformin).

发起方

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE