Clinical trial NCT04655690: A Study to Look at How Safe Insulin NNC0471-0119 is and How it Works in People With Type 1 Diabetes Mellitus
Official title: A Trial Investigation the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0471-0119 in Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of adverse events (AEs)
timeFrame: From investigational medicinal product (IMP) administration at day 1 (Visit 2) and up to 22 days post IMP administration (Visit 3)
Secondary outcomes:
measure: Number of hypoglycaemic episodes
timeFrame: 0 to 24 hours after IMP administration
measure: 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).
timeFrame: 0 to 12 hours after IMP administration
measure: 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.
timeFrame: 0 to 12 hours after IMP administration
measure: 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.
timeFrame: 0 to 12 hours after IMP administration
measure: Cmax,NNC0471-0119: Maximum observed serum NNC0471- 0119 concentration
timeFrame: 0 to 12 hours after IMP administration
measure: tmax,NNC0471-0119: Time to maximum observed serum NNC0471-0119 concentration
timeFrame: 0 to 12 hours after IMP administration
measure: t½, NNC0471-0119: Terminal half-life for NNC0471-0119
timeFrame: 0 to 12 hours after IMP administration
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: