A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: NNC0148-0287; Drug: Semaglutide; Drug: NNC0148-0287sema

Study type: Interventional

Funder types: Industry

Identifiers

NCT03789578

U1111-1204-8233 (Other Identifier)

2017-004538-27 (Registry Identifier)

NN1535-4359

Details and patient eligibility

About

The study will look at how insulin 287 and semaglutide work in the body, both when given alone or together. This study will look at the way insulin 287 and semaglutide reach and stay in participants' blood after injection when given alone or together. Participants will get 3 study medicines at 3 different time points: 1) a combination of semaglutide plus insulin 287, 2) insulin 287 alone and 3) semaglutide alone. The order in which participants get them is decided by chance. Participants will get all medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks. The study will last for about 19 to 32 weeks in total.

Enrollment: 30 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
• Diagnosed with type 2 diabetes mellitus more than or equal to 180 days prior to the day of screening
• Body weight between 80.0 to 120.0 kg (both inclusive)
• Glycosylated haemoglobin (HbA1c) 6.0 to 8.5% (both inclusive)
• No current and no regular previous intake of insulin. Previous insulin treatment for short periods of time (a maximum of 14 days) is allowed, as well as insulin use during a previous period of gestational diabetes in the past (as declared by the subject or reported in the medical records)
• Stable daily dose(s) of the following anti-diabetic drug(s)/regimen within the past 90 days prior to the day of screening: a) Any metformin formulation (dose as documented in the subject medical record), b) One other oral antidiabetic drug (dose as documented in the subject medical record) is allowed, but not mandatory: Insulin secretagogue (sulphonylureas), dipeptidyl peptidase 4 (DPP-4) inhibitor and sodium glucose co-transporter 2 (SGLT2) inhibitor

Exclusion criteria

• Known or suspected hypersensitivity to trial products or related products
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
• Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening
• Receipt of any investigational medicinal product within 90 days before screening
• History of severe allergies to drugs or foods or a history of severe anaphylactic reaction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

Semaglutide plus insulin 287

Experimental group

Description:

Participants will get a single dose of fixed-ratio combination of insulin 287 and semaglutide (NNC0148-0287sema (treatment C)).

Treatment:

Drug: NNC0148-0287sema

Semaglutide alone

Experimental group

Description:

Participants will get a single dose of semaglutide (treatment B) alone.

Treatment:

Drug: Semaglutide

Insulin 287 alone

Experimental group

Description:

Participants will get a single dose of insulin 287 (NNC0148-0287 (treatment A)) alone.

Treatment:

Drug: NNC0148-0287