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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-03-08

No results posted yet for this study

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

Interventions

DRUG

insulin icodec

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

DRUG

Insulin glargine U100

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Reporting Anchor and Disclosure (1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-07
Primary Completion
2019-12-09
Completion
2019-12-09

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03766854 on ClinicalTrials.gov