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Completed

NCT Number: NCT04655690

A Study to Look at How Safe Insulin NNC0471-0119 is and How it Works in People 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of adverse events (AEs)

    Time frame: From investigational medicinal product (IMP) administration at day 1 (Visit 2) and up to 22 days post IMP administration (Visit 3)

    Number of events

Secondary outcomes

  1. Number of hypoglycaemic episodes

    Time frame: 0 to 24 hours after IMP administration

    Number of episodes

  2. 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).

    Time frame: 0 to 12 hours after IMP administration

    % (Percent)

  3. 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.

    Time frame: 0 to 12 hours after IMP administration

  4. 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.

    Time frame: 0 to 12 hours after IMP administration

    h*pmol/L

  5. Cmax,NNC0471-0119: Maximum observed serum NNC0471- 0119 concentration

    Time frame: 0 to 12 hours after IMP administration

    pmol/L

  6. tmax,NNC0471-0119: Time to maximum observed serum NNC0471-0119 concentration

    Time frame: 0 to 12 hours after IMP administration

    Minutes

  7. t½, NNC0471-0119: Terminal half-life for NNC0471-0119

    Time frame: 0 to 12 hours after IMP administration

    Minutes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2020
Registry last updated
Jan 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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