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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin aspart; Drug: NNC0143-0406

• Registration Number: NCT02612844
• Lead Sponsor: Novo Nordisk A/S

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-11-20
• Study First Posted: 2015-11-24
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-05
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin Aspart	insulin aspart	-
NNC0143-0406	NNC0143-0406	-
NNC0143-0406	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Area under the serum NNC0143-0406 concentration-time curve	From 0 to 24 hours
Area under the glucose infusion rate-time curve	From 0 to 24 hours
The maximum glucose infusion rate	From 0 to 24 hours

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇹 Graz, Austria