A research study comparing how well different doses of the medicine NNC0487-0111 lower blood sugar in people with type 2 diabetes

JRCT ID: jRCT2031240286

Registered date:20/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes
• Date of first enrollment: 23/08/2024
• Target sample size: 50
• Countries of recruitment: United States,Japan,Bulugaria,Japan,Croatia,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Poland,Japan,Romania,Japan,Slovakia,Japan,Spain,Japan
• Study type: Interventional

Intervention(s)

A total of 432 participants with T2D are planned to be randomised in this phase 2, dose-finding study, investigating efficacy, safety, and PK properties of NNC0487-0111.
The study consists of:
-up to 3 weeks screening period
-up to 32 weeks dose-escalation period
-a minimum of 4 weeks maintenance period
-a 4-week follow-up period
The three weeks screening period will follow a two-step approach; including a V1a and a V1b. Only participants who are confirmed eligible may proceed to V1b for fitting for continuous glucose monitoring and ambulatory blood pressure monitoring. Also at V1b, the electronic device solution for patient reported outcome assessment will be made available to study participants. There must be a minimum of 5 days and maximum of 10 days between V1a and V1b, and a minimum of 11 days and a maximum of 14 days between V1b and randomisation to collect adequate CGM data.

Outcome(s)

• Primary Outcome: Change in HbA1c: From baseline (week 0) to end of treatment (week 36)
• Secondary Outcome: Change in body weight: From baseline (week 0) to end of treatment (week 36)

Key inclusion & exclusion criteria

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

Include criteria

1, Male or female, aged 18-75 years (both inclusive) at the time of signing the informed consent.
2, Diagnosed with type 2 diabetes mellitus greater or equal to 180 days before screening.
3, Stable daily dose(s) greater or equal to 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without SGLT2 inhibitor.
4, HbA1c of 7.0-10.0 procent (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
5, Body mass index between greater or equal to 23.0 and below 50.0 kg/m2.
6, Able and willing to adhere to the protocol including wearing a continuous glucose monitoring device provided for the study, as judged by the investigator.

Exclude criteria

1, 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.
2, Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
3, Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.

Related Information

• Primary Sponsor: Tsukasaki Nobuaki
• Secondary ID(s): NCT06542874