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Investigation of the safety and efficacy of once weekly NNC0519-0130 in participants with type 2 diabetes- a dose finding study(NN9541-4945)

A research study comparing how well different doses of the medicine NNC0519-0130 lower blood sugar in people with type 2 diabetes

Kamishimoto Jun

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

jphc_clinical_trials@novonordisk.com

Clinical trail information Administorator

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

+81-362661000

jphc_clinical_trials@novonordisk.com

Complete

Mar. 18, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Diagnosed with type 2 diabetes mellitus >= 180 days before screening.
- Stable daily dose(s) >=90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose: metformin with or without SGLT2 inhibitor.
- HbA1c of 7.5-10.0% (58-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.

Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.

Both

Type 2 diabetes

This is an interventional, 36-week, multi-national, multi-centre, randomised, 11 armed, dose-finding, phase 2 study. The study will be double-blinded within dose level of once weekly subcutaneously administered NNC0519-0130 and the corresponding volume-matched placebo arms. The active comparator arm with tirzepatide will be open label.

Change in HbA1c from baseline (week 0) to 12 weeks on a given maintenance dose (%-point)

+81-42-648-5551

Nov. 17, 2023

Yes

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com http://novonordisk-trials.com

Australia/Canada/India/Korea/South Africa/United States