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A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People From China With Type 2 Diabetes

NCT04857398 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-05-17

No results posted yet for this study

Summary

This study is looking at the way insulin icodec stays and moves over time in the blood after injections in Chinese people with type 2 diabetes.

Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin of the thigh. There will also be a run-in period that will last between 1 week and 8 weeks with daily doses of insulin degludec before start on insulin icodec.

The study will last for about 15 to 22 weeks. Participants will have about 17 visits with the study doctor including phone contact during your run-in period.

Participants will have blood samples taken at the clinic visits. Several samples of participants blood will be taken for up to 48 hours after getting the first and the last dose of insulin icodec.

Participants must be a Chinese person diagnosed with type 2 diabetes for at least 6 months and be on basal insulin treatment for at least 2 months before participating in the study.

Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

insulin icodec

Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin. The study will last for 15 to 22 weeks.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (Dept.1452) · Novo Nordisk A/S

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2022-04-06
Completion
2022-04-06

Countries

  • China

Study Locations

More Related Trials

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 NCT04857398 on ClinicalTrials.gov