E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
type 2 diabetes |
type 2 diabetes in failure with basal insulin |
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E.1.1.1 | Medical condition in easily understood language |
type 2 diabetes not controlled with insulin |
diabete di tipo 2 non ben controllato con insulina |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
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 |
The main objective of this study is to evaluate the effects of the addition of vildagliptin or glimepiride, in patients in failure with basal insulin and Metformin, on the time (in minutes / day) spent in euglycemia (70-140 mg / dl) |
Obiettivo primario di questo lavoro è valutare gli effetti dell’aggiunta del vildagliptin o glimepiride, in pazienti diabetici in fallimento con insulina basale (glargine, detemir) con metfomina, sul tempo (espresso in minuti/giorno) trascorso in euglicemia (70-140 mg/dl) |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives: assessment of intra-glycemic variability, on postprandial blood glucose, the total glycemic load, indices of oxidative stress and some surrogate parameters of cardiovascular risk |
Obiettivi secondari: valutazione della variabilità glicemica intragiornaliera, sulla glicemia postprandiale, sul carico glicemico totale, su indici dello stress ossidativo e su alcuni parametri surrogati di rischio cardiovascolare |
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E.2.3 | Trial contains a sub-study | No |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
EFFETTI DEL VILDAGLIPTIN E DELLA GLIMEPIRIDE SULLA VARIABILITA’ GLICEMICA E SUI PARAMETRI CARDIOVASCOLARI IN PAZIENTI AFFETTI DA DIABETE DI TIPO 2 IN FALLIMENTO CON INSULINA BASALE. version 1 11.06.2013 |
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E.3 | Principal inclusion criteria |
- age between 40 and 80 years
- Both sexes
- Treated with metformin and basal insulin
- With HbA1c between 7-9% |
età compresa tra i 40 e 80 anni
- entrambi i sessi
- in trattamento con metformina ed insulina basale
- con HbA1c tra 7-9 %
|
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E.4 | Principal exclusion criteria |
- Type 1 diabetes;
- Chronic systemic diseases, immunologic, neoplastic;
- Cardiovascular, renal and hepatic
- AST, ALT 2 times higher than the reference values
- Women who are pregnant or intend to become pregnant
- Breastfeeding women.
- Drug therapy can interfere with glucose metabolism |
- diabete di tipo 1;
- malattie sistemiche croniche, immunologiche, neoplastiche;
- patologie cardiovascolari, renali ed epatiche
- valori di AST, ALT 2 volte superiori ai valori di riferimento
- donne in gravidanza o che intendono pianificare una gravidanza,
- donne in allattamento.
- terapia farmacologica in grado di interferire con il metabolismo glucidico (es. cortisonici)
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E.5 End points |
E.5.1 | Primary end point(s) |
time (in minutes / day) spent in euglycemia (70-140 mg / dl) |
tempo (espresso in minuti/giorno) trascorso in euglicemia (70-140 mg/dl) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 0-12-24 and 52 weeks |
A 0-12-24 e 52 settimane |
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E.5.2 | Secondary end point(s) |
effects on indices intraday glycemic variability, postprandial blood glucose, total glycemic load, indices of oxidative stress and some surrogate parameters of cardiovascular risk |
variazione degli indici di variabilità glicemica intragiornaliera, sulla glicemia postprandiale, sul carico glicemico totale, su indici dello stress ossidativo e su alcuni parametri surrogati di rischio cardiovascolare |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At 0-12-24 and 52 weeks |
A 0-12-24 e 52 settimane |
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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 | Yes |
E.6.4 | Safety | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |