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)

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000359-42-IT

Enrollment

180

Registered

2021-02-10

Start date

2019-02-18

Completion date

Unknown

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly patients suffering from type 2 diabetes mellitus in treatment with metformina MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: NovoNorm 0,5mg Product Name: Repaglinide Product Code: [a10bx02] Pharmaceutical Form: Tablet INN or Proposed INN: REPAGLINIDE Current Sponsor code: Fondazione Policlinico Gemelli Roma Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 (=65 years) yes F.1.3.1 Number of subjects for this age range 180

Exclusion criteria

Exclusion criteria: Diagnosis of type 1 diabetes mellitus; impaired renal function (eGFR 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).

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactCRO

Fullcro Srl

claudia.guerrieri@fullcro.org00390658300309

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026