Skip to main content
OpenTrials
Completed

NCT Number: NCT03766854

A Research Study of How Different Amounts of a New Medicine NNC0148-0287 C (Insulin 287) Works on the Blood Sugar of People Who Are Japanese With Type 1 Diabetes When Given Once a Week

This study will look at how insulin 287 works, if it is safe and the side effects in people who are Japanese with type 1 diabetes. The study will test how insulin goes through your blood, how long it stays there and how the blood sugar is lowered. Insulin 287 is a new medicine. Insulin glargine is already approved to treat diabetes. The study doctors can prescribe insulin glargine. The participants will get both of the insulins in a random order. The participants will get 8 weekly doses of insulin 287 and 14 daily doses of insulin glargine. There will also be a run-in period of 2 days to 7 weeks when the participants inject insulin glargine every day before they start insulin 287 period or insulin glargine period. All doses will be injected under the skin. During the run-in period, the participants adjust the insulin glargine dose and make their blood sugar levels stable. From the run-in period, the participants will take insulin aspart as bolus insulin. The study will last for about 16 - 28 weeks. The participants will have 24 visits with the study doctor. There will be 3 glucose clamps where the participants' blood sugar is tested over time. The participants cannot be in the study if the study doctor thinks that there are risks for their health.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Fukuoka, 812-0025, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, Japanese subjects, aged 20 - 64 years (both inclusive) at the time of signing informed consent.
  • Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening.
  • Current daily basal insulin treatment greater than or equal to 0.2 U/kg/day.
  • Body mass index between 18.5 and 28.0 kg/m^2 (both inclusive).
  • HbA1c less than or equal to 9.0%.

Exclusion criteria

  • History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions (except conditions associated with diabetes mellitus).
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
  • Known or suspected hypersensitivity to trial products or related products

Treatment and study plan

Insulin icodec

Drug

Participants will receive subcutaneous (s.c.) injections of insulin 287 once weekly for 8 weeks

Other names: Insulin 287

Insulin glargine U100

Drug

Participants will receive s.c. injections of insulin glargine once weekly for 2 weeks

Primary outcomes

  1. AUCI287τ,SS - Area under the serum insulin 287 concentration-time curve during one dosing interval at steady state

    Time frame: From 0 to 168 hours after trial product administration (day 50)

    Measured in pmol*h/L

Secondary outcomes

  1. Number of adverse events (AEs)

    Time frame: From first trial product administration (day 1) to end of last dosing interval (day 57 for insulin 287, day 15 for IGlar)

    Number of events

  2. Number of hypoglycaemic episodes

    Time frame: From first trial product administration (day 1) to end of last dosing interval (day 57 for insulin 287, day 15 for IGlar) excluding clamp days

    Number of episodes

  3. Change in antiinsulin 287 antibody level

    Time frame: From first insulin 287 administration (day 1) to follow-up visit (day 106)

    Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer)

  4. Change in antiinsulin 287 antibody titres

    Time frame: From first insulin 287 administration (day 1) to follow-up visit (day 106)

    Number of dilutions.

    The antibody titer is calculated by diluting the blood serum sample containing antibody in serial ratios (1:2, 1:4, 1:8, 1:16... and so on). Using an appropriate detection method (e.g., colorimetric, chromatographic, etc.), each dilution is tested for the presence of detectable levels of antibody. The assigned titer value is indicative of the last dilution in which the antibody was detected.

  5. Positive cross-reactive anti-human insulin antibodies

    Time frame: At follow-up visit (day 106)

    Yes/no. Number of participants who developed/not developed positive cross-reactive anti-human insulin antibodies.

  6. AUCI287,0-168,FD - Area under the serum insulin 287 concentration-time curve after the first dose

    Time frame: From 0 to 168 hours after trial product administration (day 1)

    Measured in pmol*h/L

  7. tmax,I287,FD - Time to maximum observed serum insulin 287 concentration after the first dose

    Time frame: From 0 to 168 hours after trial product administration (day 1)

    Measured in hours

  8. Cmax,I287,FD - Maximum observed serum insulin 287 concentration after the first dose

    Time frame: From 0 to 168 hours after trial product administration (day 1)

    Measured in pmol/L

  9. tmax,I287,SS - Time to maximum observed serum insulin 287 concentration after the last dose

    Time frame: From 0 to 168 hours after trial product administration (day 50)

    Measured in hours

  10. Cmax,I287,SS - Maximum observed serum insulin 287 concentration after the last dose

    Time frame: From 0 to 168 hours after trial product administration (day 50)

    Measured in pmol/L

  11. t1/2,I287,SS - Terminal half-life for insulin 287 at steady state

    Time frame: Terminal part of the serum insulin 287 concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (day 50)

    Measured in hours

  12. CI287,trough - Serum insulin 287 trough concentration

    Time frame: Measured at the end of each dosing interval 168 hours after dosing (day 8, 15, 22, 29, 36, 43, 50 and 57)

    Measured in pmol/L

  13. AUCIGlar,τ,SS - Area under the serum IGlar concentration-time curve during one dosing interval at steady state

    Time frame: From 0 to 24 hours after trial product administration (day 14)

    Measured in pmol*h/L

  14. Cmax,IGlar,SS - Maximum observed serum IGlar concentration at steady state

    Time frame: From 0 to 24 hours after trial product administration (day 14)

    Measured in pmol/L

  15. tmax,IGlar,SS - Time to maximum observed serum IGlar concentration at steady state

    Time frame: From 0 to 24 hours from trial product administration (day 14)

    Measured in hours

  16. CIGlar,trough - Serum IGlar trough concentration

    Time frame: Measured at the end of each dosing interval 24 hours after trial product administration (day 7, 14 and 15)

    Measured in pmol/L

  17. AUCGIR,24-48h,SS - Area under the glucose infusion rate-time curve at steady state

    Time frame: From 24 to 48 hours after trial product administration (day 51)

    Measured in mg/kg

  18. GIRmax,24-48h, SS - Maximum observed glucose infusion rate at steady state

    Time frame: From 24 to 48 hours after trial product administration (day 51)

    Measured in mg/(kg*min)

  19. AUCGIR,150-168h,SS - Area under the glucose infusion rate-time curve at steady state

    Time frame: From 150 to 168 hours after trial product administration (day 57)

    Measured in mg/kg

  20. GIRmax,150-168h,SS - Maximum observed glucose infusion rate at steady state

    Time frame: From 150 to 168 hours after trial product administration (day 57)

    Measured in mg/(kg*min)

  21. AUCGIR,0-24h,SS - Area under the glucose infusion rate-time curve at steady state

    Time frame: From 0 to 24 hours after trial product administration (day 14)

    Measured in mg/kg

  22. GIRmax,0-24h,SS - Maximum observed glucose infusion rate at steady state

    Time frame: From 0 to 24 hours after trial product administration (day 14)

    Measured in mg/(kg*min)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multiple-dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) for Subcutaneous Administration in Japanese Subjects With Type 1 Diabetes

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2018
Registry last updated
Mar 8, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.