A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0268-0965 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus

This study is investigating the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentrations in the blood and its effect on blood sugar for the treatment of diabetes. This first part of the study is conducted in healthy people, while there is a second part involving people with type 1 diabetes. The study will test how insulin 965 is tolerated by the participants' body, how it is taken up in the participants' blood, how long it stays there and how blood sugar is lowered. Participants will either get the new insulin 965 or placebo (an injection that does not contain active medicine) - which treatment you get is decided by chance. It is the first time that insulin 965 is tested in humans. Participants will get one injection of either insulin 965 or placebo under the skin of the left thigh. The study will last for about 5 weeks. Participants will have 6 clinic visits with the study doctor. People cannot be in the study if the study doctor thinks that there are risks for their health.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1; Healthy Volunteers
• Intervention / Treatment: Drug: NNC0268-0965; Drug: Placebo; Drug: insulin glargine

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Part 1 (healthy subjects):

  1. Male, aged 18-55 years (both inclusive) at the time of signing informed consent.

• Part 2 (subjects with type 1 diabetes mellitus):

  1. Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
  2. Diagnosed with type 1 diabetes mellitus equal to or more than1 year prior to the day of screening.
  3. Male subject or female subject of non-child bearing potential. Non-child bearing potential being surgically sterilized (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause).
  4. Current daily total insulin treatment between 0.2 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).
  5. HbA1c equal to or below 8.5%.
  6. Fasting C-peptide below 0.30 nmol/L.

Exclusion Criteria:

• (Part 1 and Part 2) 1. Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part 1 (healthy): NNC0268-0965; A single dose of NNC0268-0965 given s.c. (subcutaneously, under the skin)	Drug: NNC0268-0965; 2 to 3 dose levels will be tested in Part 1. 3 to 5 dose levels will be tested in Part 2
PLACEBO_COMPARATOR: Part 1 (healthy): placebo; A single dose of placebo (NNC0268-0965) given s.c.	Drug: Placebo; A single dose of placebo given in Part 1
EXPERIMENTAL: Part 2 (type 1 diabetes): NNC0268-0965; A single dose of NNC0268-0965 given s.c.	Drug: NNC0268-0965; 2 to 3 dose levels will be tested in Part 1. 3 to 5 dose levels will be tested in Part 2
ACTIVE_COMPARATOR: Part 2 (type 1 diabetes): insulin glargine; A single dose of insulin glargine given s.c.	Drug: insulin glargine; Insulin glargine given at a fixed dose level of 0.5 U/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment-emergent adverse events	Number of events	From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment-emergent hypoglycaemic episodes	Number of episodes	From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10
Area under the serum NNC0268-0965 concentration-time curve after a single dose	pmol*h/L	From 0 hours until infinity after trial product administration (day 1)
Maximum observed serum NNC0268-0965 concentration after a single dose	pmol/L	From 0 hours until last measurement time after trial product administration (day 1)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 5, 2019
• Primary Completion (ACTUAL): December 14, 2019
• Study Completion (ACTUAL): December 14, 2019

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (ACTUAL): May 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

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 Glargine
• Other Study ID Numbers: NN1965-4456; 2018-003922-98 (REGISTRY: European Medicines Agency (EudraCT)); U1111-1221-9696 (REGISTRY: World Health Organization (WHO))

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