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

NCT ID: NCT03766854

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-07
• Study Completion Date: 2019-12-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin 287 followed by insulin glargine U100

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.

Group Type: EXPERIMENTAL

insulin icodec

Intervention Type: DRUG

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

Insulin glargine U100

Intervention Type: DRUG

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

Insulin glargine U100 followed by insulin 287

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.

Group Type: EXPERIMENTAL

insulin icodec

Intervention Type: DRUG

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

Insulin glargine U100

Intervention Type: DRUG

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

Interventions

insulin icodec

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

Intervention Type: DRUG

Insulin glargine U100

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

Intervention Type: DRUG

Other Intervention Names

Insulin 287

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Fukuoka, , Japan

Countries

Japan

Other Identifiers

U1111-1211-7635

Identifier Type: OTHER

Identifier Source: secondary_id

NN1436-4422

Identifier Type: -

Identifier Source: org_study_id