A Study to Look at How Safe Insulin NNC0471-0119 is and How it Works in People With Type 1 Diabetes Mellitus

A Trial Investigation the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0471-0119 in Subjects With Type 1 Diabetes Mellitus

This study is looking at the safety of the new medicine, insulin NNC0471-0119, its concentrations in the blood and effect on blood sugar for the treatment of type 1 diabetes. Insulin NNC0471-0119 will be compared to faster aspart. The purpose of this study is to test how insulin NNC0471-0119 is tolerated by participants body, how it is transported in participants bloodstream, how long it stays there and how the blood sugar is lowered compared to faster aspart. Participants will get either the new insulin NNC0471-0119 or faster aspart-which treatment participants get is decided by chance. It is the first time insulin NNC0471-0119 is tested in people. Faster aspart is a globally used medication for treatment of diabetes mellitus. Participants will get one single injection in a fasting state which will take place at the study site. The medicine will be injected under the skin in the stomach. The study will last for about 13-53 days, depending on individual visit schedule. Participants will have four clinic visits with the study doctor, one of which will require an in-house visit period of 3 days. During the in-house visit, two intravenous cannulas will be inserted for sampling of blood and infusion of insulin. Participants cannot be in the study if the study doctor thinks that there are risks to their health. Women: Women cannot take part if they are of childbearing potential.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: NNC0471-0119; Drug: Fast-acting insulin aspart

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male subject or female subject of non-childbearing potential. Non-childbearing 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 (T1DM) greater than or equal to 1 year prior to the day of screening.
• Current total daily bolus insulin treatment less than 0.7(I)U/kg/day.

Exclusion Criteria:

• Known or suspected hypersensitivity to investigational medicinal products (IMPs) or related products.
• Participation in any clinical trial of an approved or non-approved IMP within 90 days before screening.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC0471-0119; Participants randomised to NNC0471-0119	Drug: NNC0471-0119; Participants will be randomised to either of five dose levels 0.3, 0.6, 1.2, 2.4 or 3.6 of NNC0471-0119 nanomol per kilogram body weight, which will be administered as a single dose. NNC0471-0119 will be administered subcutaneously (s.c., under the skin) in fasting state.
Active Comparator: Faster aspart; Participants randomised to faster aspart.	Drug: Fast-acting insulin aspart; Participants will get a fixed dose of 0.2 units of fast-acting insulin aspart (Fiasp®) per kilogram body weight, administered subcutaneously (s.c., under the skin) in fasting state.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events (AEs)	Number of events	From investigational medicinal product (IMP) administration at day 1 (Visit 2) and up to 22 days post IMP administration (Visit 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hypoglycaemic episodes	Number of episodes	0 to 24 hours after IMP administration
AUCNNC0471-0119,0-30 min/AUCNNC0471-0119,0-t: Ratio of the area under the serum NNC0471-0119 concentration-time curve from 0-30 min and 0-t, where t is the last observed time point with insulin concentration above lower limit of quantification (LLOQ).	% (Percent)	0 to 12 hours after IMP administration
AUCNNC0471-0119,2h-t/AUCNNC0471-0119,0-t: Ratio of the area under the serum NNC0471-0119 concentration-time curve from 2 hours to t and 0 to t, where t is the last observed time point with insulin concentration above LLOQ.		0 to 12 hours after IMP administration
AUCNNC0471-0119, 0-t: Area under the serum NNC0471-0119 concentration-time curve from 0 to t, where t is the last observed time point with insulin concentration above LLOQ.	h*pmol/L	0 to 12 hours after IMP administration
Cmax,NNC0471-0119: Maximum observed serum NNC0471- 0119 concentration	pmol/L	0 to 12 hours after IMP administration
tmax,NNC0471-0119: Time to maximum observed serum NNC0471-0119 concentration	Minutes	0 to 12 hours after IMP administration
t½, NNC0471-0119: Terminal half-life for NNC0471-0119	Minutes	0 to 12 hours after IMP administration

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): November 26, 2021
• Study Completion (Actual): November 26, 2021

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Estimate): January 2, 2023
• Last Update Submitted That Met QC Criteria: December 30, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Aspart
• Other Study ID Numbers: NN1471-4612; U1111-1247-7440 (Other Identifier: World Health Organization (WHO)); 2020-000665-16 (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