A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes

June 25, 2023 updated by: Novo Nordisk A/S

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Healthy Subjects and in Subjects With Type 1 Diabetes

This study is investigating the safety and tolerability of the new investigational product NNC0363-0845, its concentrations in the blood and its effect on the blood sugar for the treatment of diabetes. The study consists of 3 parts. The first part of the study is conducted in healthy people, while the second part involves people with type 1 diabetes (T1D). Part 3 of this trial involves also people with T1D.

The study will test how NNC0363-0845 is tolerated by the body, how it is taken up in the blood, how long it stays there and how much the blood sugar is lowered. Healthy volunteers will either get NNC0363-0845 or placebo - which treatment is decided by chance. Participants with type 1 diabetes will either get NNC0363-0845 or insulin degludec (Tresiba®), also decided by chance. It is the first time that NNC0363-0845 is tested in humans. Participants will get one dose of NNC0363-0845 or placebo or insulin degludec injected into their left thigh. Participation in the study will last for up to 6 weeks. There will be one Informed Consent visit and 6 clinic visits with the study doctor. Healthy volunteers will have blood sampling to measure blood sugar and the concentration of the investigational product in the blood. Participants with type 1 diabetes will have a clamp experiment where the blood sugar is measured and controlled for up to 42 hours.

For Part 3, the total duration of the trial for each individual is expected to be approximately 3-9 weeks.

Participants cannot be in the study if the study doctor thinks that there are risks for their health. Women can only take part in the study if they are of non-child bearing potential.

Study Overview

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mainz, Germany, 55116
        • Novo Nordisk INvestigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Part 1 (healthy subjects):

  • Male subject or female subject of non-child bearing 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 18-55 years (both inclusive) at the time of signing informed consent.
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Part 2 and 3 (subjects with type 1 diabetes mellitus):

  • Male subject or female subject of non-child bearing 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 18-55 years (both inclusive) at the time of signing informed consent.
  • Diagnosed with type 1 diabetes mellitus 1 year or more prior to the day of screening.
  • Glycated haemoglobin (HbA1c) equal to or below 8.5%.
  • Fasting C-peptide below 0.30 nmol/L.
  • Considered to be generally healthy (except for type 1 diabetes mellitus and sequelae of diabetes which may only be of mild severity) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

Part 1 (healthy subjects) Part 2 and Part 3 (subjects with type 1 diabetes mellitus):

- Male of reproductive age who or whose 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 subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1
Healthy volunteers will receive either NNC0363-0845 or placebo
A single dose administered s.c. (subcutaneously, under the skin)
A single dose administered s.c.
Experimental: Part 2
Participants with T1D will receive either NNC0363-0845 or insulin degludec
A single dose administered s.c. (subcutaneously, under the skin)
A single dose administered s.c.
Experimental: Part 3
Participants with T1D will receive NNC0363-0845
A single dose administered s.c. (subcutaneously, under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment-emergent adverse events (AEs)
Time Frame: Part 1 and 2: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10
Number of events
Part 1 and 2: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10
Number of treatment-emergent adverse events (AEs)
Time Frame: Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1)
Number of events
Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment-emergent hypoglycaemic episodes
Time Frame: Part 1 and 2 From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10
Number of episodes
Part 1 and 2 From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10
Number of treatment-emergent hypoglycaemic episodes
Time Frame: Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1)
Number of episodes
Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1)
Area under the serum NNC0363-0845 concentration-time curve from 0 to infinity after a single dose
Time Frame: Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1)
pmol*h/L
Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1)
Area under the serum NNC0363-0845 concentration-time curve from 0 to infinity after a single dose
Time Frame: Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1)
pmol*h/L
Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1)
Maximum observed serum NNC0363-0845 concentration after a single dose
Time Frame: Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1)
pmol/L
Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1)
Maximum observed serum NNC0363-0845 concentration after a single dose
Time Frame: Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1)
pmol/L
Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Clinical Transparency and Medical Writing Office (1452), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2020

Primary Completion (Actual)

June 23, 2021

Study Completion (Actual)

June 23, 2021

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (Actual)

September 30, 2020

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 25, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • NN1845-4598
  • U1111-1244-4315 (Other Identifier: World Health Organization (WHO))
  • 2019-004658-27 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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