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Completed

NCT Number: NCT03965013

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Volunteers Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Part 1 (healthy subjects):
  • Male, aged 18-55 years (both inclusive) at the time of signing informed consent.
  • Part 2 (subjects with type 1 diabetes mellitus):
  • Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
  • Diagnosed with type 1 diabetes mellitus equal to or more than1 year prior to the day of screening.
  • 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).
  • Current daily total insulin treatment between 0.2 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).
  • HbA1c equal to or below 8.5%.
  • 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.

Treatment and study plan

NNC0268-0965

Drug

2 to 3 dose levels will be tested in Part 1. 3 to 5 dose levels will be tested in Part 2

Placebo

Drug

A single dose of placebo given in Part 1

insulin glargine

Drug

Insulin glargine given at a fixed dose level of 0.5 U/kg

Primary outcomes

  1. Number of treatment-emergent adverse events

    Time frame: From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10

    Number of events

Secondary outcomes

  1. Number of treatment-emergent hypoglycaemic episodes

    Time frame: From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10

    Number of episodes

  2. Area under the serum NNC0268-0965 concentration-time curve after a single dose

    Time frame: From 0 hours until infinity after trial product administration (day 1)

    pmol*h/L

  3. Maximum observed serum NNC0268-0965 concentration after a single dose

    Time frame: From 0 hours until last measurement time after trial product administration (day 1)

    pmol/L

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 28, 2019
Registry last updated
Jan 14, 2021

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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