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

NCT03766854 | Completed Phase 1

• 2 other identifiers: NN1436-4422U1111-1211-7635
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• AUCI287τ,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)

• Number of adverse events (AEs)

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

• Number of hypoglycaemic episodes

  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

• Change in antiinsulin 287 antibody level

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

• Change in antiinsulin 287 antibody titres

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

• Positive cross-reactive anti-human insulin antibodies

  At follow-up visit (day 106)

Study Arms (2)

Insulin 287 followed by insulin glargine U100

EXPERIMENTAL

Run-in period (2 days to 7 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 (PK) 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: Insulin glargine U100

Insulin glargine U100 followed by insulin 287

EXPERIMENTAL

Run-in period (2 days to 7 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 OW for 8 weeks and subsequent 4 weeks of terminal PK sampling.

Drug: insulin icodec; Drug: Insulin glargine U100

Interventions

insulin icodec DRUG

Participants will receive subcutaneous (s.c.) 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

Insulin glargine U100 DRUG

Participants will receive s.c. 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: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Fukuoka, 812-0025, Japan

Location

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: December 4, 2018
• First Posted: December 6, 2018
• Study Start: December 7, 2018
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)