WHO ICTRP trial
A Research Study to Compare Two Semaglutide Medicines in People with Type 2…
EUCTR2021-001501-69-SK · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2021-001501-69-SK |
|---|---|
| Public title | A Research Study to Compare Two Semaglutide Medicines in People with Type 2 Diabetes |
| Scientific title | Investigation of Clinical Comparability of Semaglutide Drug Products Based on the Proposed and the Approved Drug Substance Manufacturing Processes in Participants with Type 2 Diabetes |
| Primary sponsor | Novo Nordisk A/S |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Canada;United States;European Union;South Africa;Slovakia |
| Conditions | Diabetes mellitus, Type 2 MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] |
| Interventions | Trade Name: Ozempic Pharmaceutical Form: Solution for injection INN or Proposed INN: SEMAGLUTIDE CAS Number: 910463-68-2 Other descriptive name: Semaglutide Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal… |
| Registration date | Apr 25, 2022 |
| Target size | 380 |
| Secondary IDs | NN9535-4820 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: