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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612844
• Other study ID #: NN1406-4209
• Secondary ID: 2014-005334-63U1
• Status: Completed
• Phase: Phase 1
• First received: November 20, 2015
• Last updated: December 5, 2017
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: December 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• NNC0143-0406
Subject will receive one single dose only Subcutanesously (s.c., under the skin)
• insulin aspart
Subject will receive one single dose only. Subcutanesously (s.c., under the skin)

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of treatment emergent adverse events		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	Area under the serum NNC0143-0406 concentration-time curve		From 0 to 24 hours
Secondary	Area under the glucose infusion rate-time curve		From 0 to 24 hours
Secondary	The maximum glucose infusion rate		From 0 to 24 hours

External Links

•   Clinical Trials at Novo Nordisk