A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week

NCT03723772 | Completed Phase 1

• 3 other identifiers: NN1436-4225U1111-1204-89092017-004528-31
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the new long-acting insulin 287 with the marketed insulin glargine for use in type 1 diabetes. The study will test how insulin is taken up in your blood, how long it stays there and how the blood sugar is lowered. The participant will get both of the insulins in a random order. Insulin 287 is a new medicine while insulin glargine is already approved for the treatment of diabetes and can be prescribed by a doctor. The participant 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 4 weeks with daily doses of insulin glargine before you start the insulin 287 period. All doses will be injected under the skin. The study will last for about 16 to 24 weeks. The participant will have 27 visits with the study doctor.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• AUCI287,τ,SS - Area under the serum insulin 287 concentration-time curve during one dosing interval at steady state

  Measured in pmol\*h/L

  From 0 to 168 hours after trial product administration (Day 50)

Secondary Outcomes (22)

• AUCGIR,16-52h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state

  From 16 to 52 hours after trial product administration (Day 50)

• AUCGIR,138-168h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state

  From 138 to 168 hours after trial product administration (Day 50)

• GIRmax,16-52h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state

  From 16 to 52 hours after trial product administration (Day 50)

• GIRmax,138-168h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state

  From 138 to 168 hours after trial product administration (Day 50)

• AUCGIR,0-24h,SS (for insulin glargine) - Area under the glucose infusion rate-time curve at steady state

  From 0 to 24 hours after trial product administration (Day 14)

Study Arms (2)

Insulin 287 followed by insulin glargine U100

EXPERIMENTAL

Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised. After run-in, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling where subjects are treated with once daily (OD) insulin glargine. After insulin 287 treatment, participants will receive insulin glargine U100 OD for 2 weeks.

Drug: Insulin icodec; Drug: IGlar U100

Insulin glargine U100 followed by insulin 287

EXPERIMENTAL

Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised. After run-in, participants will receive insulin glargine U100 OD for 2 weeks followed by 1-14 days (at least 1 day is mandatory) of continued insulin glargine treatment. After insulin glargine treatment, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling.

Drug: Insulin icodec; Drug: IGlar U100

Interventions

Insulin icodec DRUG

Participants will receive subcutaneous injections of insulin 287 once weekly for 8 weeks

Also known as: Insulin 287

Insulin 287 followed by insulin glargine U100; Insulin glargine U100 followed by insulin 287

IGlar U100 DRUG

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

Insulin 287 followed by insulin glargine U100; Insulin glargine U100 followed by insulin 287

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 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 29.0 kg/m\^2 (both inclusive)
• HbA1c less than or equal to 9.0%

You may not qualify if:

• History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions. Subjects with complications associated to diabetes can be included only if they are judged to be mild by the investigator. Subjects with other comorbidities (e.g. dyslipidaemia, hypertension and hypothyroidism) can be included if they have a stable treatment and are in adequate control according to the judgement of the investigator- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
• Known or suspected hypersensitivity to trial products or related products

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Related Publications (1)

• Hovelmann U, Engberg S, Heise T, Kristensen NR, Norgreen L, Zijlstra E, Ribel-Madsen R. Pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in individuals with type 1 diabetes. Diabetes Obes Metab. 2024 May;26(5):1941-1949. doi: 10.1111/dom.15510. Epub 2024 Feb 20.

  PMID: 38379002 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin icodec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune 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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: November 29, 2018
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)