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)
- Conditions
- Elderly patients suffering from type 2 diabetes mellitus in treatment with metforminaMedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2018-000359-42-IT
- Lead Sponsor
- FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effects of linagliptin 5 mg once daily versus repaglinide 0.5 mg three times daily on muscle markers of sarcopenia and physical performance in elderly subjects with type 2 diabetes on metformin therapy;Secondary Objective: NA;Primary end point(s): The study will compare the variation in 24 weeks of the following parameters between participants receiving linagliptin and repaglinide: Muscles strenght (handgrip strenght, measured by a dynamome; Physical function, measured by Short Physical Performance Battery; Muscles mass, measured by Bioimpedanceometry (BIA).;Timepoint(s) of evaluation of this end point: 24 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Changes from baseline values after 24 weeks of treatment of: Metabolic control, Cognitive function, Biological and molecular markers linked to the inflammatory and oxidative state, Use of health resources.;Timepoint(s) of evaluation of this end point: 24 weeks