E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes mellitus |
2-es típusú cukorbetegség |
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E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes mellitus |
2-es típusú cukorbetegség |
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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 | 20.0 |
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 demonstrate that, efpeglenatide doses 1 and 2 is noninferior to placebo on 3-point major adverse cardiac event (MACE) in Type 2 diabetes mellitus (T2DM) patients at high cardiovascular (CV) risk. |
Annak igazolása, hogy a 4 és 6 mg efpeglenatid a 3 pontos MACE értékelése alapján nem rosszabb a placebóhoz képest magas szív-érrendszeri (CV) kockázatú, 2-es típusú cukorbetegségben (T2DM) szenvedő betegek körében |
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E.2.2 | Secondary objectives of the trial |
-To demonstrate that efpeglenatide doses 1 and 2 is superior to placebo in T2DM patients with high CV risk on the following parameters:
-3-point MACE
-Expanded CV outcome.
-Composite outcome of new or worsening nephropathy.
-To assess the safety and tolerability of efpeglenatide doses 1 and 2, both added to standard of care in T2DM patients at high CV risk. |
-Annak igazolása, hogy magas szív-érrendszeri kockázatú, 2-es típusú cukorbetegségben szenvedő betegek körében a 4 és 6 mg efpeglenatid jobb a placebóhoz képest az alábbiak tekintetében:
-3 pontos MACE
-a CV kimenetel kiterjesztett értékelése alapján
-az új vagy rosszabbodó nefropátia összetett kimenetelének értékelése alapján
-A 4, illetve 6 mg efpeglenatid biztonságosságának és tolerálhatóságának értékelése, amelyet mindkét hatáserősség esetén a szokásos ellátás mellett alkalmaznak.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) > 7%.
-Age 18 years or older with established cardiovascular disease or age 50 years (male), 55 years (female) or older with eGFR ≥25 and <60 mL/min and at least one cardiovascular risk factor.
-Male and female patients must agree to follow contraceptive guidance.
-Signed written informed consent. |
-2-es típusú cukorbetegség és a glikált hemoglobin A1c (HbA1c) >7%.
-18 éves vagy idősebb, bizonyítottan szív-érrendszeri beteg, vagy legalább egy szív-érrendszeri kockázattal rendelkező, legalább 50 éves férfi, vagy legalább 55 éves nő beteg, akinek az EGFR értéke ≥25 és <60 ml/perc.
-Az előírt fogamzásgátlásba beleegyező férfi és nő beteg.
-Aláírt betegtájékoztató és beleegyező nyilatkozat.
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E.4 | Principal exclusion criteria |
-Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting.
-History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any type of acute pancreatitis.
-Personal or family history of medullary thyroid cancer (MTC)
-Hypertension (with a systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg).
-Hospitalization for hypertensive emergency within 3 months prior to randomization
-Planned coronary procedure or surgery after randomization.
-No documented ophthalmologic exam with fundoscopy within 6 months prior to screening
-Retinopathy or maculopathy with treatment, either recent (3 months prior to randomization) or planned during the study
-Treated with any glucagon-like peptide-1 (GLP-1) receptor agonist products (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) within 3 months prior to screening.
-Use of any DPP4 inhibitor within 12 weeks prior to screening
-Antihyperglycemic treatment has not been stable within 12 weeks prior to screening. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to first Major Adverse Cardiovascular Event (MACE): Time to the first occurrence of any of the following clinical events: cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline to approximately 36 months |
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E.5.2 | Secondary end point(s) |
1) Time to first expanded cardiovascular outcome event: Time to the first occurrence of any of the following clinical events, positively adjudicated by the clinical endpoint committee (CEC): cardiovascular death, non-fatal MI, non-fatal stroke, coronary revascularization, hospitalization for unstable angina.
2) Time to first composite renal event: Time to the first occurrence of any of the following clinical events: new onset or progression to macro albuminuria (>300 mg/g) accompanied by a UACR value increase of ≥30% from baseline, sustained ≥40% decrease in eGFR from baseline (for ≥30 days), chronic dialysis (for ≥90 days), renal transplant, sustained eGFR <15 mL/min/1.73 m2 (for ≥30 days).
3) Adverse Events (AEs): Number of patients with AEs |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) to 3) Baseline to approximately 36 months |
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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) | 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 | 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 | 14 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 123 |
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 |
Argentina |
Brazil |
Bulgaria |
Canada |
Chile |
Denmark |
Estonia |
Finland |
Germany |
Hungary |
India |
Italy |
Korea, Republic of |
Latvia |
Lithuania |
Mexico |
Norway |
Peru |
Poland |
Romania |
Russian Federation |
Serbia |
Slovakia |
South Africa |
Spain |
Sweden |
Turkey |
Ukraine |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |