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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938572
• Other study ID #: NN1406-4218
• Secondary ID: 2014-005340-18U1
• Status: Completed
• Phase: Phase 1
• First received: October 17, 2016
• Last updated: February 23, 2018
• Start date: October 19, 2016
• Est. completion date: July 4, 2017

Study information

• Verified date: February 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 4, 2017
• Est. primary completion date: June 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• NNC0143-0406
Administered subcutaneously (s.c. under the skin)
• Insulin Aspart
Administered subcutaneously (s.c. under the skin)

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ratio of suppression of endogenous glucose production relative to total glucose lowering effect		Two weeks of treatment
Secondary	Number of treatment emergent adverse events		Time of first trial product administration to 7 days (7 times 24 hours) after last trial product administration