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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: NNC0143-0406; Drug: Insulin Aspart

• Registration Number: NCT02938572
• Lead Sponsor: Novo Nordisk A/S

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-18
• Study Start: 2016-10-19
• Study First Posted: 2016-10-19
• Primary Completion: 2017-06-17
• Study Completion: 2017-07-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-23
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NNC0143-0406	NNC0143-0406	-
Insulin aspart	Insulin Aspart	-

Primary Outcome Measures

Name	Time	Method
The ratio of suppression of endogenous glucose production relative to total glucose lowering effect	Two weeks of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇹 Graz, Austria