A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants With Type 1 Diabetes Pharmacokinetics and Pharmacodynamics: How Insulin NNC0363-0845 is Transported Throughout the Body and How It Works

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: NNC0363-0845; Drug: Insulin detemir

• Registration Number: NCT05134987
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is designed to investigate the movement of insulin NNC0363-0845 throughout the body and how it works for the treatment of type 1 diabetes mellitus.

The aim of the study is to improve clinical outcomes for patients with type 1 diabetes mellitus by better controlling the blood sugar levels.

Participants will get insulin NNC0363-0845 as well as insulin detemir (Levemir®). NNC0363-0845 is a new insulin molecule designed to provide blood sugar-dependent insulin action, while insulin detemir is commonly used and prescribed by doctors.

Participants will get subcutaneous (under your skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days, and of insulin detemir up to 6 times daily for another 3 days. Which medication participants receive first and which second, insulin NNC0363-0845 or insulin detemir, is decided by chance.

The study will last for about 6 weeks up to a maximum of 14 weeks. Participants will have 2 in-house visits (where participants will stay at the site for 4 nights) and 5 outpatient visits with the study doctor. Participants will have frequent contact with the study doctor during the study.

During the in-house visits, two intravenous catheters (a thin tube inserted into a vein) will be inserted for blood sampling and infusions.

Interested parties may not participate in the study if the study doctor believes it will affect their health negatively.

Women cannot take part if they are of childbearing potential.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-26
• Study Start: 2021-12-01
• Primary Completion: 2022-05-06
• Study Completion: 2022-05-06
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NNC0363-0845 followed by insulin detemir	NNC0363-0845	Participants will get subcutaneous (under the skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of insulin detemir up to 6 times daily for 3 days.
Insulin detemir followed by NNC0363-0845	Insulin detemir	Participants will get subcutaneous (under the skin) injections of insulin detemir up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of NNC0363-0845 (study medicine) up to 6 times daily for 3 days.

Primary Outcome Measures

Name	Time	Method
AUCPG,0.5-2h Area under the plasma glucose-time curve at steady concentrations	From 0.5 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)	messured in h\*mmol/L

Secondary Outcome Measures

Name	Time	Method
∆PGav,0-1h Mean change in plasma glucose at steady concentrations	From 0 to 1 hour after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)	messured in mmol/L
∆PGav,0-2h Mean change in plasma glucose at steady concentrations	From 0 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)	messured in mmol/L
Number of adverse events	From first IMP administration until 16 hours after last IMP administration (visit 4 day 3 and visit 5 day 3)	Number of events
AUCPG,0-1h Area under the plasma glucose-time curve at steady concentrations	From 0 to 1 hour after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)	messured in h\*mmol/L
AUCPG,0-2hArea under the plasma glucose-time curve at steady concentrations	From 0 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)	messured in h\*mmol/L
AUCPG,0-4h Area under the plasma glucose-time curve at steady concentrations	From 0 to 4 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)	messured in h\*mmol/L

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇹 Graz, Austria