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 A/S30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

AUCI287, 0-tz, area under the serum insulin 287 concentration-time curve from 0 hours to last quantifiable observation after a single dose

Measured in pmol\*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.

Time frame: 0-840 hours

AUCSema,0-tz, area under the plasma semaglutide concentration-time curve from 0 hours to last quantifiable observation after a single dose

Measured in pmol\*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.

Time frame: 0-840 hours

Secondary Outcomes

AUCI287,0-∞ area under the serum insulin 287 concentration-time curve from 0 hours to infinity after a single dose

Measured in pmol\*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.

Time frame: 0-840 hours

Cmax, I287, maximum observed serum insulin 287 concentration after a single dose

Measured in pmol/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.

Time frame: 0-840 hours

tmax, I287, time to maximum observed serum insulin 287 concentration after a single dose

Measured in hour (h) for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.

Time frame: 0-840 hours

AUCSema,0-∞, area under the plasma semaglutide concentration-time curve from 0 hours to infinity after a single dose

Measured in pmol\*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.

Time frame: 0-840 hours

Cmax,Sema, maximum observed plasma semaglutide concentration after a single dose

Measured in pmol/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.

Time frame: 0-840 hours

tmax,Sema, time to maximum observed plasma semaglutide concentration after a single dose

Measured in hour (h) for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.

Time frame: 0-840 hours

Number of treatment emergent adverse events

Count of events.

Time frame: Day 1 (beginning of each period) to day 36 (end of each period)

Number of hypoglycaemic episodes

Count of episodes.

Time frame: Day 1 (beginning of each period) to day 36 (end of each period)

Antibodies for insulin 287: Change in anti-insulin 287 binding antibody levels

Measured as percentage B/T following administration of NNC0148 -0287sema and insulin 287.

Time frame: Day -1 (pre-dose), Day 36 (end of period)

Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies

Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287.

Time frame: Day 36 (end of period)

Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin

Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287.

Time frame: Day 36 (end of period)

Antibodies for semaglutide: Change in anti-semaglutide binding antibody levels

Measured as percentage B/T following administration of NNC0148 -0287sema

Time frame: Day -1 (pre-dose), Day 36 (end of period)

Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies

Percentage of events (yes/no) following administration of NNC0148 -0287sema.

Time frame: Day 36 (end of period)

Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous glucagon-like peptide-1 (GLP-1)

Percentage of events (yes/no) following administration of NNC0148 -0287sema.

Time frame: Day 36 (end of period)

Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-semaglutide binding antibody levels

Measured as percentage B/T.