E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 2 |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 16.1 |
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 | 100000004861 |
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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 compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes |
Porovnať účinok dvoch dávkovacích hladín semaglutidu pri dávkovaní jedenkrát týždenne a inzulínu glargín v dávke jedenkrát denne na glykemickú kontrolu po 30 týždňoch liečby u doteraz inzulínom neliečených pacientov s diabetom 2. typu. |
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E.2.2 | Secondary objectives of the trial |
To compare the effects of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily after 30 weeks of treatment on:
- Inducing and maintaining weight loss
- Other parameters of efficacy, safety, tolerability and patient reported outcomes |
Porovnať účinky dvoch dávkovacích hladín semaglutidu pri dávkovaní jedenkrát týždenne a inzulínu glargín v dávke jedenkrát denne po 30 týždňoch liečby na:
- vyvolanie a udržanie zníženej hmotnosti
- ďalšie ukazovatele účinnosti, bezpečnosti, znášanlivosti a pacientom hlásených výsledkov
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, age ≥18 years at the time of signing informed consent
2. Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin ≥1500 mg or maximum tolerated dose and SU ≥ half of maximum allowed dose according to national label) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
3. HbA1c 7.0 – 10.0% (53 - 86 mmol/mol) both inclusive |
1. Muž alebo žena, vek ≥18 rokov v čase podpísania informovaného súhlasu.
2.Doteraz inzulínom neliečení pacienti s diagnózou diabetu 2. typu a na stabilnej diabetickej liečbe metformínom alebo metformínom a SU (metformín ≥1500 mg alebo najvyššia tolerovaná dávka a SU ≥ polovica najvyššej povolenej dávky podľa národnej klasifikácie) počas najmenej 90 dní pred skríningom. Stabilná liečba je definovaná ako nezmenená medikácia a nezmenená dávka.
3. HbA1c 7,0 – 10,0% (53 - 86 mmol/mol), v oboch prípadoch vrátane
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E.4 | Principal exclusion criteria |
1. Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
2. Any disorder which, in the opinion of the Investigator might jeopardise subject’s safety or compliance with the protocol
3. Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (≤7 days in total) with insulin in connection with intercurrent illness
4. History of chronic or idiopathic acute pancreatitis
5. Screening calcitonin value ≥50 ng/L
6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
7. Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
8. Acute coronary or cerebrovascular event within 90 days before randomisation
9. Heart failure, New York Heart Association Class IV
10. Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
11. Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
12. Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures |
1. Žena, ktorá je gravidná, dojčí alebo sa chystá otehotnieť alebo žena, ktorá môže otehotnieť a nepoužíva primerané antikoncepčné metódy (primerané antikoncepčné opatrenia vyžadované podľa miestnych nariadení alebo praxe) počas celého klinického skúšania vrátane 5-týždňového obdobia ďalšieho sledovania (follow-up).
2.Akékoľvek ochorenie, ktoré môže podľa názoru skúšajúceho lekára ohroziť bezpečnosť pacienta alebo komplianciu s protokolom.
3. Liečba akýmkoľvek prostriedkom/-kami znižujúcim hladinu glukózy, iným, ako je stanovené v inklúznych kritériách, počas obdobia 90 dní pred skríningom. Výnimkou je krátkodobá liečba (celkovo ≤7 dní) inzulínom súvisiaca s pridruženým ochorením.
4. Chronická alebo idiopatická akútna pankreatitída v minulosti.
5. Skríningová hodnota kalcitonínu ≥50 ng/L.
6. Medulárny karcinóm štítnej žľazy alebo syndróm mnohonásobnej endokrinnej neoplázie typu 2 v osobnej alebo rodinnej anamnéze.
7.Závažná porucha funkcie obličiek definovaná ako eGFR <30 mL/min/1,73 m2 podľa vzorca pre úpravu stravy pri ochorení obličiek (MDRD) (verzia so 4 premennými).
8. Akútna srdcová alebo cerebrovaskulárna príhoda počas 90 dní pred randomizáciou.
9. Zlyhanie srdca, trieda IV podľa klasifikácie New York Heart Association.
10. Známa proliferatívna retinopatia alebo makulopatia vyžadujúca podľa názoru skúšajúceho lekára akútnu liečbu.
11. Diagnóza zhubného nádoru v priebehu predošlých 5 rokov (okrem rakoviny bazálnych buniek kože alebo rakoviny skvamóznych buniek kože).
12. Duševná neschopnosť, neochota alebo jazyková bariéra znemožňujúca adekvátne pochopenie alebo komplianciu s protokolom klinického skúšania.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c |
Zmena hodnoty HbA1c |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to week 30 |
Od vstupného vyšetrenia po 30. týždeň |
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E.5.2 | Secondary end point(s) |
1. Change in body weight
2. Change in fasting plasma glucose (FPG)
3. Change in systolic and diastolic blood pressure
4. Change in patient reported outcome questionnaires (PROs), SF-36v2™ and DTSQs
5. Subjects who achieve HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE)
target (yes/no) |
1. Zmena telesnej hmotnosti
2. Zmena v hodnotách plazmovej glukózy nalačno (FPG)
3. Zmena v systolickom a diastolickom tlaku krvi
4. Zmena v dotazníkoch zameraných na pacientom hlásené výsledky (PROs), SF-36v2™ a DTSQs
5. Pacienti, ktorí dosiahnu (áno/nie): cieľovú hodnotu Americkej asociácie klinických endokrinológov (AACE) HbA1c ≤6,5% (48 mmol/mol)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.- 4. From baseline to week 30
5. After 30 weeks' treatment |
1.- 4. Od vstupného vyšetrenia po 30. týždeň
5. Po 30 týždňoch liečby |
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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 | 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 |
Tolerability and patient reported outcomes |
Znášanlivosť a pacientom hlásené výsledky |
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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 | 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 | 3 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 62 |
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 |
Argentina |
India |
Macedonia, the former Yugoslav Republic of |
Mexico |
South Africa |
United States |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 1 |