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Completed

NCT Number: NCT03789578

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Other names: Ozempic®

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.

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

    Time frame: 0-840 hours

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

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

    Time frame: 0-840 hours

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

Secondary outcomes

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

    Time frame: 0-840 hours

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

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

    Time frame: 0-840 hours

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

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

    Time frame: 0-840 hours

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

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

    Time frame: 0-840 hours

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

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

    Time frame: 0-840 hours

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

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

    Time frame: 0-840 hours

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

  7. Number of treatment emergent adverse events

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

    Count of events.

  8. Number of hypoglycaemic episodes

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

    Count of episodes.

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

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

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

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

    Time frame: Day 36 (end of period)

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

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

    Time frame: Day 36 (end of period)

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

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

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

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

  13. Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies

    Time frame: Day 36 (end of period)

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

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

    Time frame: Day 36 (end of period)

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

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

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

    Measured as percentage B/T.

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

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

    Percentage of events (yes/no).

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

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

    Measured as percentage B/T.

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

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

    Percentage of events (yes/no).

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

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

    Percentage of events (yes/no).

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

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

    Percentage of events (yes/no).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial to Investigate Single Dose Pharmacokinetics of NNC0148-0287sema in a Fixed Ratio Compared With Insulin 287 and Semaglutide Given Separately in Subjects With Type 2 Diabetes

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 28, 2018
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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