Geriatric outcomes among older Type 2 diabetic patients treated with DPP4 inhibitors or glinides: focus on cognitive functioning (GOOD-WP3)
- Conditions
- type 2 diabetes mellitusMedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-004663-12-IT
- Lead Sponsor
- A.O.U. Università degli Studi della Campania Luigi Vanvitelli
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 146
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from baseline after 24 weeks of treatment of:<br>•fasting plasma glucose (FPG)<br>•glycosylated hemoglobin (HbA1C)<br>•markers of inflammation and oxidative stress (TNF-a, IL1ß; IL6, IL18, nitrotyrosine)<br>•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)<br>•lean muscle mass (DEXA);<br>•incidence of major comorbidities;<br>•physical performance (SPPB);<br>•cognitive impairment (MMSE);<br>•risk of depression (GDS);<br>•malnutrition/undernutrition (MNA);<br>•health-related quality of life (EQ-5D);<br>•use of healthcare resources.;Timepoint(s) of evaluation of this end point: change from baseline after 24 weeks of treatment