Investigation of the safety and efficacy of semaglutide s.c. in combination with NNC0480-0389 in participants with type 2 diabetes - a dose finding study(NN9389-4606)

JRCT ID: jRCT2031210474

Registered date:10/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 29/11/2021
• Target sample size: 495
• Countries of recruitment: Bulgaria,Japan,Denmark,Japan,Greece,Japan,Hungary,Japan,Poland,Japan,Russia,Japan,Serbia,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

All study arms will contain once-weekly s.c. co-administered separate injections of semaglutide (or semaglutide matched placebo) and NNC0480-0389 (or NNC0480-0389 matched placebo). The 10 study arms consist of 6 active treatment arms and 4 placebo arms, as follows:

-2.4 mg semaglutide and 2.4 mg NNC0480-0389
-2.4 mg semaglutide and 7.2 mg NNC0480-0389
-2.4 mg semaglutide and 12.0 mg NNC0480-0389
-2.4 mg semaglutide and 21.6 mg NNC0480-0389
-NNC0480-0389 21.6 mg and semaglutide placebo
-Semaglutide 2.4 mg and NNC0480-0389 placebo
-4 placebo arms matching the dose ratio arms: each with semaglutide matched placebo and NNC0480-0389 matched placebo

The study consists of an up to 2-week screening period followed by a 34-week intervention period and a 5-week follow-up period. To perform assessments specified in the protocol

Outcome(s)

• Primary Outcome: Change from baseline in HbA1c (%)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both
• Include criteria: Participants treated with diet and exercise as monotherapy or in combination with stable daily dose of any metformin formulations
• Exclude criteria: Severe heart failure, History of chronic pancreatitis, other

Related Information

• Primary Sponsor: Oyatani Akihito
• Secondary ID(s): 2020-004863-14