E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 2 |
|
E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes |
Diabetes 2. typu |
|
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 | 18.0 |
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 | 100000004861 |
|
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 subcutaneous semaglutide (0.5 mg and 1.0 mg) versus once-weekly dosing of two dose levels of subcutaneous dulaglutide (0.75 mg and 1.5 mg) on glycaemic control in subjects with type 2 diabetes on a background treatment with metformin. |
Porovnávať účinok dvoch rôznych dávok semaglutidu (0,5 mg a 1,0 mg) a dulaglutidu (0,75 mg a 1,5 mg) pri podávaní raz týždenne subkutánne na kontrolu glykémie u pacientov s diabetom typu 2 pri súčasnej liečbe metformínom. |
|
E.2.2 | Secondary objectives of the trial |
To compare the effect of once-weekly dosing of two dose levels of subcutaneous semaglutide (0.5 mg and 1.0 mg) versus once-weekly dosing of two dose levels of subcutaneous dulaglutide (0.75 mg and 1.5 mg) in subjects with type 2 diabetes on a background treatment with metformin with regards to:
- Body weight control
- Blood pressure
- Patient reported outcomes
- Safety and tolerability |
Porovnať účinok aplikácie dvoch dávkovacích hladín (0,5 mg a 1,0 mg) subkutánneho semaglutidu jedenkrát týždenne voči aplikácii dvoch dávkovacích hladín (0,75 mg a 1,5 mg) subkutánneho dulaglutidu jedenkrát týždenne u pacientov s diabetom typu 2 pri súčasnej liečbe metformínom vzhľadom ku:
- Telesnej hmotnosti
- Krvnému tlaku
- Dotazníkoch zameraných na kvalitu života pacientov (PRO)
- Bezpečnosti a tolerabilite |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female, age ≥ 18 years at the time of signing informed consent.
- HbA1c 7.0 – 10.5% (53 – 91 mmol/mol) (both inclusive)
- Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening |
- Muž alebo žena, vek ≥ 18 rokov v čase podpisu informovaného súhlasu.
- HbA1c 7,0 – 10,5% (53 – 91 mmol/mol) (zahŕňajúc obe hodnoty)
- Pacienti so stabilnou liečbou diabetu metformínom (minimum 1500 mg/deň alebo maximálnou tolerovanou dávkou dokumentovanou v zdravotnej dokumentácii pacienta) po 90 dní pred skríningom. |
|
E.4 | Principal exclusion criteria |
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
- Any condition, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of ≤14 days
- History of pancreatitis (acute or chronic)
- Screening calcitonin ≥50 ng/L
- Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
- Renal impairment defined as eGFR < 60 mL/min/1.73 m^2 as per CKD-EPI
- Subjects presently classified as being in New York Heart Association Class IV
- Planned coronary, carotid or peripheral artery revascularisation on the day of screening
- Proliferative retinopathy or maculopathy requiring acute treatment
- History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids) |
- Žena ktorá je tehotná, dojčiaca, plánuje otehotnieť alebo je možné, že otehotnie a nepoužíva adekvátnu metódu antikoncepcie
(adekvátne antikoncpečné opatrenia vyžadované lokálnymi usmerneniami alebo praxou).
- Akékoľvek podmienky, ktoré podľa názoru investigátora môžu ohroziť pacientovu bezpečnosť alebo dodržiavanie podmienok protokolu
- Liečba akýmkoľvek prípravkom na liečbu diabetu alebo obezity mimo uvedených inklúznych kritérií počas 90 dňového obdobia pred skríningom. Výnimkou je krátkodobá liečba inzulínom pre akútne ochorenie v celkovom trvaní ≤14 dní
- História pankreatitídy (akútnej alebo chronickej)
- Skríningová hodnota kalcitonínu ≥50 ng/L
- Rodinná alebo osobná anamnéza mnohopočetnej endokrinnej neoplázie typu 2 alebo medulárneho tyroidného karcinómu
- Obličková nedostatočnosť definovaná ako eGFR < 60 mL/min/1,73 m2 podľa CKD-EPI
- Pacienti v súčasnosti klasifikovaní ako štádium IV podľa Newyorkskej asociácie kardiológov (New York Heart Association)
- Plánovaná koronárna, karotická alebo periférna arteriálna revaskularizácia v čase skríningu
- Proliferatívna retinopatia alebo makulopatia vyžadujúca akútnu liečbu
- História alebo prítomnosť malígnej neoplázie v rámci posledných 5 rokov (okrem bazocelulárneho alebo skvamózneho kožného karcinómu a karcinómov in situ)
- Predpokladané zahájenie alebo zmena konkomitantnej liečby (pre viac ako 14 po sebe idúcich dní alebo na frekventnej báze) s potenciálom ovplyvniť hmotnosť alebo metabolizmus glukózy (napr. orlistat, tyroidálne hormóny, kortikosteroidy) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c |
Zmena hodnoty HbA1c |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to week 40 |
od vstupného vyšetrenia po 40. týždeň |
|
E.5.2 | Secondary end point(s) |
Change in
1. Body weight (kg)
2. Fasting plasma glucose
3. Systolic and diastolic blood pressure
4. Overall scores for patient reported outcomes: Diabetes Treatment Satisfaction Questionnaire
5. Subjects who achieve (yes/no) HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists target |
Zmena v:
-Telesnej hmotnosti
- Plazmatická glukóza nalačno
- Systolický a diastolický tlak krvi
- Celkové skóre v rámci pacientom reportovaných výsledkov: Dotazník zameraný na spokojnosť pacienta s liečbou |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-4. From baseline to week 40
5. After 40 weeks treatment |
1-4. od vstupného vyšetrenia po 40. týždeň
5. po 40 týždňovej liečbe |
|
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 | 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) | 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 | 4 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 85 |
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 |
Canada |
European Union |
Hong Kong |
India |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 18 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 18 |