A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes

Novo Nordisk

Status and phase: Enrolling; Phase 2

Conditions: Type 2 Diabetes (T2D)

Treatments: Drug: Placebo (NNC0487-0111 oral); Drug: NNC0487-0111 oral; Drug: NNC0487-0111 subcutanous; Drug: Placebo (NNC0487-0111 subcutanous)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06542874

U1111-1296-9708 (Other Identifier)

NN9490-7678

2023-509412-28 (Other Identifier)

Details and patient eligibility

About

The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.

Enrollment: 432 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, aged 18-75 years (both inclusive) at the time of signing the informed consent.
• Diagnosed with type 2 diabetes mellitus greater or equal to 180 days before screening.
• 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.
• HbA1c of 7.0-10.0 procent (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
• Body mass index between greater or equal to 23.0 and below 50.0 kg/m^2.
• Able and willing to adhere to the protocol including wearing a continuous glucose monitoring (CGM) device provided for the study, as judged by the investigator.

Exclusion 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.
• 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.
• Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

432 participants in 11 patient groups, including a placebo group

Placebo subcutaneous

Placebo Comparator group

Description:

Placebo for subcutaneous treatment

Treatment:

Drug: Placebo (NNC0487-0111 subcutanous)

NNC0487-0111 subcutaneous dose 1

Experimental group

Description:

NNC0487-0111 subcutaneous dose 1 treatment

Treatment:

Drug: NNC0487-0111 subcutanous

NNC0487-0111 subcutaneous dose 2

Experimental group

Description:

NNC0487-0111 subcutaneous dose 2 treatment

Treatment:

Drug: NNC0487-0111 subcutanous

NNC0487-0111 subcutaneous dose 3

Experimental group

Description:

NNC0487-0111 subcutaneous dose 3 treatment

Treatment:

Drug: NNC0487-0111 subcutanous

NNC0487-0111 subcutaneous dose 4

Experimental group

Description:

NNC0487-0111 subcutaneous dose 4 treatment

Treatment:

Drug: NNC0487-0111 subcutanous

NNC0487-0111 subcutaneous dose 5

Experimental group

Description:

NNC0487-0111 subcutaneous dose 5 treatment

Treatment:

Drug: NNC0487-0111 subcutanous

NNC0487-0111 subcutaneous dose 6

Experimental group

Description:

NNC0487-0111 subcutaneous dose 6 treatment

Treatment:

Drug: NNC0487-0111 subcutanous

Placebo oral

Placebo Comparator group

Description:

Placebo for oral treatment

Treatment:

Drug: Placebo (NNC0487-0111 oral)

NNC0487-0111 oral dose 1

Experimental group

Description:

NNC0487-0111 oral dose 1 treatment

Treatment:

Drug: NNC0487-0111 oral

NNC0487-0111 oral dose 2

Experimental group

Description:

NNC0487-0111 oral dose 2 treatment

Treatment:

Drug: NNC0487-0111 oral

NNC0487-0111 oral dose 3

Experimental group

Description:

NNC0487-0111 oral dose 3 treatment

Treatment:

Drug: NNC0487-0111 oral