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

JRCT ID: jRCT2031230704

Registered date:15/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 18/03/2024
• Target sample size: 35
• Countries of recruitment: Australia,Japan,Canada,Japan,India,Japan,Korea,Japan,South Africa,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

- 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.

• Exclude criteria: 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.

Related Information

• Primary Sponsor: Takase Juri