A Randomised Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus

NCT ID: NCT02938572

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-19
• Study Completion Date: 2017-07-04

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate Pharmacodynamics (the effect of the investigated drug on the body) , Pharmacokinetics (the exposure of the trial drug in the body), and Safety of NNC0143-0406 in Subjects with Type 1 Diabetes Mellitus

Conditions

Diabetes; Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NNC0143-0406

Group Type: EXPERIMENTAL

NNC0143-0406

Intervention Type: DRUG

Administered subcutaneously (s.c. under the skin)

Insulin aspart

Group Type: ACTIVE_COMPARATOR

Insulin Aspart

Intervention Type: DRUG

Administered subcutaneously (s.c. under the skin)

Interventions

NNC0143-0406

Administered subcutaneously (s.c. under the skin)

Intervention Type: DRUG

Insulin Aspart

Administered subcutaneously (s.c. under the skin)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female 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
• Treated with continuous subcutaneous insulin infusion at least 90 days prior to the day of screening

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 ontraceptive, a contraceptive patch, a diaphragm or intrauterine device, together with a physical barrier such as condom. Male subjects must also agree to refrain from sperm donation from randomisation until 90 days after last dosing
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) (adequate contraceptive measures are defined as sterilisation, hormonal intrauterine device, oral contraceptives, condom with spermicide sexual abstinence or vasectomised partner)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Graz, , Austria

Countries

Austria

Other Identifiers

2014-005340-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1164-6715

Identifier Type: OTHER

Identifier Source: secondary_id

NN1406-4218

Identifier Type: -

Identifier Source: org_study_id