E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus Type 2 |
Diabete Mellito Tipo 2 |
|
E.1.1.1 | Medical condition in easily understood language |
Diabetes Mellitus Type 2 |
Diabete Mellito Tipo 2 |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
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 confirm the efficacy of IDeg compared to placebo, both in combination with liraglutide and metformin, in controlling glycaemia |
Confermare l'efficacia di IDeg rispetto al placebo, entrambi in associazione con liraglutide e metformina, nel controllo della glicemia |
|
E.2.2 | Secondary objectives of the trial |
To assess other efficacy parameters, safety and patient reported outcomes (PROs) of IDeg compared to placebo, both in combination with liraglutide and metformin |
Valutare altri parametri di efficacia, sicurezza e gli esiti riferiti dai pazienti attraverso il questionario sulla salute e sul benessere (PRO, Patient Reported Outcome) di IDeg rispetto a placebo, entrambi in combinazione con liraglutide e metformina. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. > or = 18 years of age;
2. Type 2 diabetes;
3. Insulin naïve;
4. Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU) or DPP-IV inhibitors or exenatide (only BID);
5. HbA1c as assessed by central laboratory:
- 7.5-10.0% (both inclusive) for subjects on metformin monotherapy;
- 7.0-9.0% (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID); |
1. > or = 18 anni;
2. Diabete di tipo 2;
3. Insulina naive;
4. Trattamento in corso con metformina o metformina in combinazione con sulfonilurea (SU) o glinidi o inibitori del DPP-IV o exenatide (solo BID);
5. HbA1c valutata dal laboratorio centrale:
- 7,5-10,0% (entrambi inclusi) per i soggetti in monoterapia con metformina;
- 7,0-9,0% (entrambi inclusi) per i soggetti in terapia con metformina in combinazione con SU, glinidi, inibitori del DPP-IV o exenatide(solo BID); |
|
E.4 | Principal exclusion criteria |
-Calcitonin > or = 50 pg/mL;
-Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks prior to Visit 1;
-Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma); |
-Calcitonina > o = 50 pg/mL;
-Ictus, Infarto del miocardio New York Heart Association (NYHA) classe III o IV, angina pectoris instabile, o bypass coronarico o angioplastica delle arterie, il tutto entro le 24 settimane precedenti la Visita 1;
-Attuali o passate (negli ultimi 5 anni) neoplasie maligne (ad eccezione dei carcinomi delle cellule basali e delle cellule squamose della pelle); |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline to 26 weeks of randomised treatment in HbA1c (%) |
• Variazione rispetto al valore basale di HbA1c (%) dopo 26 settimane di trattamento randomizzato |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 26 weeks of randomised treatment |
dopo 26 settimane di trattamento randomizzato |
|
E.5.2 | Secondary end point(s) |
Key Secondary efficacy endpoints:
-Change from baseline in FPG;
-Number of responders for HbA1c (< 7.0 %);
-Change from baseline in mean pre-breakfast measurements used for titration;
-Change from baseline in 8-point profile;
-Change from baseline in mean of the 8-point profile;
Key Secondary safety endpoints:
-Number of hypoglycaemic episodes;
-Number of adverse events;
-Changes from baseline in patient reported healt-related quality of life (PRO); |
Principali End point secondari di efficacia:
-Variazione rispetto al basale della FPG;
-Numero di pazienti responder per l’HbA1c (<7,0%);
-Variazione rispetto al basale delle misurazioni medie pre-colazione usate per la titolazione;
-Variazione rispetto al basale del profilo glicemico a 8 punti;
-Variazione rispetto al basale della media del profilo glicemico a 8 punti;
Principali End point secondari di sicurezza:
-Numero di ipoglicemie;
-Numero di eventi avversi;
-Cambiamento dalla basale della valutazione dei risultati dei questionari sulla salute e benessere (PRO); |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 26 weeks of randomised treatment |
dopo 26 settimane di trattamento randomizzato |
|
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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Patient reported outcome (PRO) |
Questionari sulla Salute e sul Beneserre (PRO) |
|
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
European Union |
Canada |
Israel |
South Africa |
Ukraine |
United Arab Emirates |
United States |
|
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
|
|
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 | 14 |
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 | 14 |
E.8.9.2 | In all countries concerned by the trial days | 0 |