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CompletedNCT03789578Updated Nov 12, 2024

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

A Phase 1 interventional study of NNC0148-0287sema and Semaglutide in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Semaglutide plus insulin 287

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

    Drug: NNC0148-0287sema

  • Experimental
    Semaglutide alone

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

    Drug: Semaglutide

  • Experimental
    Insulin 287 alone

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

    Drug: NNC0148-0287

Interventions

  • DrugNNC0148-0287sema

    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.

  • DrugSemaglutide

    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®

  • DrugNNC0148-0287

    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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Number of treatment emergent adverse events

    Count of events.

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

  8. Number of hypoglycaemic episodes

    Count of episodes.

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

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

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

    Measured as percentage B/T.

    Time frame: Day 151 (follow-up/end-of-trial visit)

  16. Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous GLP-1

    Percentage of events (yes/no).

    Time frame: Day 151 (follow-up/end-of-trial visit)

  17. Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-insulin 287 binding antibody levels

    Measured as percentage B/T.

    Time frame: Day 151 (follow-up/end-of-trial visit)

  18. Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin

    Percentage of events (yes/no).

    Time frame: Day 151 (follow-up/end-of-trial visit)

  19. Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies

    Percentage of events (yes/no).

    Time frame: Day 151 (follow-up/end-of-trial visit)

  20. Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies cross reacting with endogenous GLP-1

    Percentage of events (yes/no).

    Time frame: Day 151 (follow-up/end-of-trial visit)

07

Study locations

1 site
  • Profil Institut für Stoffwechselforschung GmbH
    Neuss, 41460, Germany
08

References and documents

Publications

  • 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. PubMed 39488821 ↗

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03789578
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 28, 2018
Start date
Jan 17, 2019
Primary completion
Oct 10, 2019
Completion
Oct 10, 2019
Last update
Nov 12, 2024

Study contacts

Clinical Reporting Anchor and Disclosure (1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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