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

NCT ID: NCT02612844

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NNC0143-0406

Group Type EXPERIMENTAL

NNC0143-0406

Intervention Type DRUG

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

insulin aspart

Intervention Type DRUG

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

Insulin Aspart

Group Type ACTIVE_COMPARATOR

insulin aspart

Intervention Type DRUG

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

Interventions

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NNC0143-0406

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

Intervention Type DRUG

insulin aspart

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Graz, , Austria

Site Status

Countries

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Austria

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2014-005334-63

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1164-6630

Identifier Type: OTHER

Identifier Source: secondary_id

NN1406-4209

Identifier Type: -

Identifier Source: org_study_id