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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT02938572

Collaborator

(none)

Enrollment

Location

Arms

8.5

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 1	Drug: NNC0143-0406 Drug: Insulin Aspart	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 19, 2016

Actual Primary Completion Date :

Jun 17, 2017

Actual Study Completion Date :

Jul 4, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NNC0143-0406	Drug: NNC0143-0406 Administered subcutaneously (s.c. under the skin)
Active Comparator: Insulin aspart	Drug: Insulin Aspart Administered subcutaneously (s.c. under the skin)

Arm

Intervention/Treatment

Experimental: NNC0143-0406

Drug: NNC0143-0406

Administered subcutaneously (s.c. under the skin)

Active Comparator: Insulin aspart

Drug: Insulin Aspart

Administered subcutaneously (s.c. under the skin)

Outcome Measures

Primary Outcome Measures

The ratio of suppression of endogenous glucose production relative to total glucose lowering effect [Two weeks of treatment]

Secondary Outcome Measures

Number of treatment emergent adverse events [Time of first trial product administration to 7 days (7 times 24 hours) after last trial product administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Graz		Austria	8010

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT02938572

Other Study ID Numbers:

NN1406-4218
2014-005340-18
U1111-1164-6715

First Posted:

Oct 19, 2016

Last Update Posted:

Feb 26, 2018

Last Verified:

Feb 1, 2018

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Insulin Aspart

Study Results

No Results Posted as of Feb 26, 2018