A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: NNC0480-0389; Drug: Placebo (semaglutide); Drug: Placebo (NNC080-0389); Drug: Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05144984

NN9389-4606

jRCT2031210474 (Other Identifier)

U1111-1259-2741 (Other Identifier)

2020-004863-14 (EudraCT Number)

Details and patient eligibility

About

This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes.

The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies.

Participants will either get:

Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine).

NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance.

Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo.

Participant must inject the study medicines themself into the stomach, thigh, or upper arm.

The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study.

Women can only take part in the study if they are not able to become pregnant

Enrollment: 500 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
• Participants treated with diet and exercise as monotherapy or in combination with stable daily dose(s) greater than or equal to 90 days before screening of any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose
• HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
• BMI greater than or equal to 25 and below 40 kg/m^2

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 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
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 10 patient groups, including a placebo group

2.4 mg semaglutide + 2.4 mg NNC0480-0389

Experimental group

Description:

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.

Treatment:

Drug: Semaglutide

Drug: NNC0480-0389

Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)

Placebo Comparator group

Description:

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).

Treatment:

Drug: Placebo (NNC080-0389)

Drug: Placebo (semaglutide)

2.4 mg semaglutide + 7.2 mg NNC0480-0389

Experimental group

Description:

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide

Treatment:

Drug: Semaglutide

Drug: NNC0480-0389

2.4 mg semaglutide + 12.0 mg NNC0480-0389

Experimental group

Description:

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide

Treatment:

Drug: Semaglutide

Drug: NNC0480-0389

2.4 mg semaglutide + 21.6 mg NNC0480-0389

Experimental group

Description:

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide

Treatment:

Drug: Semaglutide

Drug: NNC0480-0389

NNC0480-0389 + placebo (semaglutide)

Experimental group

Description:

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide)

Treatment:

Drug: Placebo (semaglutide)

Drug: NNC0480-0389

Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)

Placebo Comparator group

Description:

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).

Treatment:

Drug: Placebo (NNC080-0389)

Drug: Placebo (semaglutide)

Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)

Placebo Comparator group

Description:

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).

Treatment:

Drug: Placebo (NNC080-0389)

Drug: Placebo (semaglutide)

Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)

Placebo Comparator group

Description:

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).

Treatment:

Drug: Placebo (NNC080-0389)

Drug: Placebo (semaglutide)

Semaglutide 2.4 mg + placebo (NNC0480-0389)

Experimental group

Description:

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide.

Treatment:

Drug: Semaglutide

Drug: Placebo (NNC080-0389)