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

NCT03789578 | Completed Phase 1

• 3 other identifiers: NN1535-4359U1111-1204-82332017-004538-27
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  0-840 hours

Secondary Outcomes (20)

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

  0-840 hours

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

  0-840 hours

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

  0-840 hours

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

  0-840 hours

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

  0-840 hours

Study Arms (3)

Semaglutide plus insulin 287

EXPERIMENTAL

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

Drug: NNC0148-0287sema

Semaglutide alone

EXPERIMENTAL

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

Drug: Semaglutide

Insulin 287 alone

EXPERIMENTAL

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

Drug: NNC0148-0287

Interventions

NNC0148-0287sema DRUG

Study staff will inject NNC0148-0287sema, 175unit (U)/0.5 mg in the morning after fasting under the skin of participants' thigh using a needle and a pen.

Semaglutide plus insulin 287

Semaglutide DRUG

Study staff will inject semaglutide, 0.5 mg alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.

Also known as: Ozempic®

Semaglutide alone

NNC0148-0287 DRUG

Study staff will inject insulin 287 (NNC0148-0287), 175U alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.

Insulin 287 alone

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Related Publications (1)

• Westergaard L, Alifrangis L, Buckley ST, Coester HV, Klitgaard T, Kristensen NR, Nishimura E, Norgreen L, Rocha TMP, Steensgaard DB, Vegge A, Plum-Morschel L. Pharmacokinetic Properties of a Once-Weekly Fixed-Ratio Combination of Insulin Icodec and Semaglutide Compared with Separate Administration of Each Component in Individuals with Type 2 Diabetes Mellitus. Clin Drug Investig. 2024 Nov;44(11):849-861. doi: 10.1007/s40261-024-01405-8. Epub 2024 Nov 3.

  PMID: 39488821 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a three-period cross-over trial. The treatments to be used are: Treatment A: insulin 287, Treatment B: semaglutide, and Treatment C: NNC0148-0287sema. The subjects will be randomised to one of the six treatment sequences in the trial: 1) ABC, 2) ACB, 3) BAC, 4) BCA, 5) CAB, and 6) CBA. The trial includes a screening visit followed by three 5 -week periods with pharmacokinetic sampling after single dose administration. The dose periods are separated by a 1-4 week washout period (from last pharmacokinetic sampling to next dosing). The follow-up period is 1-4 weeks after last pharmacokinetic sampling in period 3 (i.e. 6 to 9 weeks after last trial product administration). The total trial duration for the individual subjects participating in the trial will be 19 to 32 weeks (including follow-up), depending on individual visit schedules.

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 28, 2018
• Study Start: January 17, 2019
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)