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Completed

NCT Number: NCT02612844

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of the trial is to investigate the Safety, Tolerability,Pharmacokinetics (the exposure of the trial drug in the body) and Pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects with Type 1 Diabetes

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Key information

Age range

18 year–55 year

Sex eligibility

Male

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, aged 18-55 years (both inclusive) at the time of signing informed consent
  • Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
  • Body mass index between 18.5 and 28.0 kg/m^2 (both inclusive)

Exclusion criteria

  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Males who are sexually active and not surgically sterilised (vasectomy or otherwise) and their partners that are not using a highly effective contraception method, from randomisation until 90 days after dosing, such as double barrier contraception (e.g. condom and spermicide) or combination of either an oral contraceptive, a contraceptive patch, a diaphragm or intrauterine device, together with a physical barrier such as condom. Malesubjects must also agree to refrain from sperm donation from randomisation until 90 days after dosing
  • History or presence of any clinically relevant respiratory, metabolic (including dyslipidaemia), renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus)
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 90 days prior to screening
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the last 180 days

Treatment and study plan

NNC0143-0406

Drug

Subject will receive one single dose only Subcutanesously (s.c., under the skin)

insulin aspart

Drug

Subject will receive one single dose only. Subcutanesously (s.c., under the skin)

Primary outcomes

  1. The number of treatment emergent adverse events

    Time frame: From the time of dosing (Visit 2,Day 1) and until completion of the post-treatment follow-up visit (Visit 3) i.e. 11-13 days.

Secondary outcomes

  1. Area under the serum NNC0143-0406 concentration-time curve

    Time frame: From 0 to 24 hours

  2. Area under the glucose infusion rate-time curve

    Time frame: From 0 to 24 hours

  3. The maximum glucose infusion rate

    Time frame: From 0 to 24 hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 24, 2015
Registry last updated
Dec 6, 2017

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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