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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: NNC0143-0406

Drug: Insulin Aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT02938572

2014-005340-18 (EudraCT Number)

U1111-1164-6715 (Other Identifier)

NN1406-4218

Details and patient eligibility

About

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

Enrollment

47 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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)