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

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ClinicalTrials.gov Identifier: NCT02938572
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
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

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

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Study Type : Interventional  (Clinical Trial)
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 : October 19, 2016
Actual Primary Completion Date : June 17, 2017
Actual Study Completion Date : July 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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)




Primary Outcome Measures :
  1. The ratio of suppression of endogenous glucose production relative to total glucose lowering effect [ Time Frame: Two weeks of treatment ]

Secondary Outcome Measures :
  1. Number of treatment emergent adverse events [ Time Frame: Time of first trial product administration to 7 days (7 times 24 hours) after last trial product administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938572


Locations
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Austria
Novo Nordisk Investigational Site
Graz, Austria, 8010
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02938572     History of Changes
Other Study ID Numbers: NN1406-4218
2014-005340-18 ( EudraCT Number )
U1111-1164-6715 ( Other Identifier: WHO )
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs