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

NCT04655690 | Completed Phase 1

• 3 other identifiers: NN1471-4612U1111-1247-74402020-000665-16
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of hypoglycaemic 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).

  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.

  0 to 12 hours after IMP administration

• Cmax,NNC0471-0119: Maximum observed serum NNC0471- 0119 concentration

  0 to 12 hours after IMP administration

Study Arms (2)

NNC0471-0119

EXPERIMENTAL

Participants randomised to NNC0471-0119

Drug: NNC0471-0119

Faster aspart

ACTIVE COMPARATOR

Participants randomised to faster aspart.

Drug: Fast-acting insulin aspart

Interventions

NNC0471-0119 DRUG

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.

NNC0471-0119

Fast-acting insulin aspart DRUG

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.

Faster aspart

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Graz, 8010, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: December 7, 2020
• Study Start: November 9, 2020
• Primary Completion: November 26, 2021
• Study Completion: November 26, 2021
• Last Updated: January 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)