E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Elderly patients suffering from type 2 diabetes mellitus in treatment with metformina |
Pazienti anziani affetti da diabete mellito di tipo 2 in terapia con metformina |
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E.1.1.1 | Medical condition in easily understood language |
Elderly patient suffering from type 2 diabetes mellitus |
Pazienti anziani affetti da diabete mellito di tipo 2 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
Valutare gli effetti del linagliptin 5 mg una volta al giorno rispetto a repaglinide 0,5 mg tre volte al giorno sui marcatori muscolari di sarcopenia e di performance fisica nei soggetti anziani con diabete di tipo 2 in terapia con metformina. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 (<1m/s); written informed consent signed and dated. |
Diagnosi di diabete mellito di tipo 2; pazienti maschi e femmine pre-trattati con una dose invariata di metformina almeno 4 settimane prima della visita di randomizzazione. La dose di metformina è definita come dose massima tollerata; età = 70 anni; HbA1c = 7,5%; rischio di sarcopenia: bassa forza di prensione (uomini = 30,0 kg, donne = 20,0 kg) o abituale lentezza nella velocità della camminata (<1m / s); consenso informato scritto firmato e datato. |
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E.4 | Principal exclusion criteria |
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). |
Diagnosi di diabete mellito di tipo 1; funzione renale compromessa (eGFR < 30 ml/min per 1,73 m2); tumore maligno attivo nei 24 mesi precedenti lo screening; insufficienza cardiaca NYHA III-IV; uso di agonisti GLP-1 o terapia DPP-IV negli ultimi 3 mesi; pregressa pancreatite; patologie epatiche (i test di funzionalità epatica superano per più di 3 volte il limite superiore di normalità); bronco pneumopatia cronico ostruttiva (BPCO); ipertensione non controllata (BP> 160/100 mm di Hg); ipersensibilità nota a linagliptin e/o repaglinide o ingredienti inattivi; aspettativa di vita inferiore a 6 mesi; diagnosi di demenza; dipendenza completa nelle attività di base della vita quotidiana (BADL); partecipazione ad altri studi clinici pazienti non disposti a fornire il consenso e coloro che non possono effettuare il follow-up, oppure incapaci di eseguire le procedure previste dallo studio; trattamento con farmaci contro l'obesità, corticosteroidi sistemici o farmaci antinfiammatori non steroidei, qualsiasi altro medicinale anti-diabetico, inclusa la terapia insulinica (eccetto metformina). |
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E.5 End points |
E.5.1 | 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). |
Lo studio comparerà la variazione in 24 settimane dei seguenti parametri tra partecipanti che ricevono linagliptin e repaglinide: Forza muscolare (handgrip strength), misurata tramite dinamomentro; Funzione fisica, misurata tramite Short Physical Performance Battery; Massa muscolare, misurata tramite Bioimpedenziometria (BIA). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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. |
Cambiamenti rispetto ai valori rilevati al baseline dopo 24 settimane di trattamento di: Controllo metabolico ,• Funzione cognitiva , Marcatori biologici e molecolari legati allo stato infiammatorio e ossidativo, Utilizzo di risorse sanitarie. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
double-dummy |
double-dummy |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |