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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134987
• Other study ID #: NN1845-4886
• Secondary ID: U1111-1266-41622
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2021
• Est. completion date: May 6, 2022

Study information

• Verified date: November 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 6, 2022
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Key inclusion criteria:

• Male participant or female participant of non-childbearing potential. Non-child-bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.

• Aged 18-64 years (both inclusive) at the time of signing informed consent.

• Diagnosed with type 1 diabetes mellitus 1 year or more before screening.

• Current daily basal insulin treatment greater than 0.2 and below or equal to 0.5 (I)U/kg/day.

• Current total daily insulin treatment between 0.4 and 0.8 (I)U/kg/day (both inclusive).

• Body mass index between 18.5-29.9 kg/m^2 (both inclusive).

• HbA1c (glycated haemoglobin) below or equal to 8.0%.

Key exclusion criteria:

• Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male participant uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%). In addition, participants must not donate sperm for the duration of the study.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• NNC0363-0845
Participants will receive 0.5 nmol/kg NNC0363-0845 s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 3 nmol/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks
• Insulin detemir
Participants will receive 0.083 U/kg insulin detemir s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 0.5 U/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCPG,0.5-2h Area under the plasma glucose-time curve at steady concentrations	messured in h*mmol/L	From 0.5 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)
Secondary	AUCPG,0-1h Area under the plasma glucose-time curve at steady concentrations	messured in h*mmol/L	From 0 to 1 hour after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)
Secondary	AUCPG,0-2hArea under the plasma glucose-time curve at steady concentrations	messured in h*mmol/L	From 0 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)
Secondary	AUCPG,0-4h Area under the plasma glucose-time curve at steady concentrations	messured in h*mmol/L	From 0 to 4 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)
Secondary	?PGav,0-1h Mean change in plasma glucose at steady concentrations	messured in mmol/L	From 0 to 1 hour after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)
Secondary	?PGav,0-2h Mean change in plasma glucose at steady concentrations	messured in mmol/L	From 0 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)
Secondary	Number of adverse events	Number of events	From first IMP administration until 16 hours after last IMP administration (visit 4 day 3 and visit 5 day 3)