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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004663-12-IT

Enrollment

146

Registered

2021-05-24

Start date

2019-05-08

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

type 2 diabetes mellitus 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 - 0.5 MG COMPRESSE-30 COMRESSE IN BLISTER Product Name: Novonorm Product Code: [NA] Pharmaceutical Form: Tablet INN or Proposed INN: 00248000 CAS Number: 135062-02-1 Current Spons

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 (=65 years) yes F.1.3.1 Number of subjects for this age range 146

Exclusion criteria

Exclusion criteria: diagnosis of type 1 diabetes mellitus; impaired kidney 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 nonsteroidal anti-inflammatory drugs, any other anti-diabetic medication including insulin therapy (except metformin).

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess the effects of linagliptin 5 mg once daily vs. repaglinide 0.5 mg thrice daily on cognitive and physical decline in older T2DM) subjects using a metformin therapy;Secondary Objective: To evaluate the impact of DPP$ or glinides on physical and cognitive decline;Primary end point(s): Change from baseline after 24 weeks of treatment of incidence of major comorbidities, physical performance (SPPB), cognitive impairment (MMSE), risk of depression (GDS) before and after linagliptin use as compared to repaglinide.;Timepoint(s) of evaluation of this end point: Change from baseline after 24 weeks of treatment	—

Measure

Time frame

Main Objective: to assess the effects of linagliptin 5 mg once daily vs. repaglinide 0.5 mg thrice daily on cognitive and physical decline in older T2DM) subjects using a metformin therapy;Secondary Objective: To evaluate the impact of DPP$ or glinides on physical and cognitive decline;Primary end point(s): Change from baseline after 24 weeks of treatment of incidence of major comorbidities, physical performance (SPPB), cognitive impairment (MMSE), risk of depression (GDS) before and after linagliptin use as compared to repaglinide.;Timepoint(s) of evaluation of this end point: Change from baseline after 24 weeks of treatment

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Secondary

Measure	Time frame
Secondary end point(s): Change from baseline after 24 weeks of treatment of: • fasting plasma glucose (FPG) • glycosylated hemoglobin (HbA1C) • markers of inflammation and oxidative stress (TNF-a, IL1ß; IL6, IL18, nitrotyrosine) • biological and molecular markers linked to diabetes (plasma and exosomal inflamma-miRs (Front Genet. 2013; 4: 121) such as Mir-21, Mir-126, Mir-146, Mir-181, AGE (advanced glycation endproducts), RAGE (receptor for advanced glycation endproducts) • lean muscle mass (DEXA); • incidence of major comorbidities; • physical performance (SPPB); • cognitive impairment (MMSE); • risk of depression (GDS); • malnutrition/undernutrition (MNA); • health-related quality of life (EQ-5D); • use of healthcare resources.;Timepoint(s) of evaluation of this end point: change from baseline after 24 weeks of treatment	—

Measure

Time frame

Secondary end point(s): Change from baseline after 24 weeks of treatment of: • fasting plasma glucose (FPG) • glycosylated hemoglobin (HbA1C) • markers of inflammation and oxidative stress (TNF-a, IL1ß; IL6, IL18, nitrotyrosine) • biological and molecular markers linked to diabetes (plasma and exosomal inflamma-miRs (Front Genet. 2013; 4: 121) such as Mir-21, Mir-126, Mir-146, Mir-181, AGE (advanced glycation endproducts), RAGE (receptor for advanced glycation endproducts) • lean muscle mass (DEXA); • incidence of major comorbidities; • physical performance (SPPB); • cognitive impairment (MMSE); • risk of depression (GDS); • malnutrition/undernutrition (MNA); • health-related quality of life (EQ-5D); • use of healthcare resources.;Timepoint(s) of evaluation of this end point: change from baseline after 24 weeks of treatment

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Countries

Italy

Contacts

Public ContactU.O.C. Geriatria e Medicina Interna

Azienda Ospedaliera Universitaria "Luigi Vanvitelli"

giuseppe.paolisso@unicampania.it0815665303

Outcome results

None listed

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