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Trial record 29 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02612844
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The aim of the trial is to investigate the Safety, Tolerability,Pharmacokinetics (the exposure of the trial drug in the body) and Pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects with Type 1 Diabetes

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 : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects With Type 1 Diabetes
Study Start Date : November 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: NNC0143-0406 Drug: NNC0143-0406
Subject will receive one single dose only Subcutanesously (s.c., under the skin)

Drug: insulin aspart
Subject will receive one single dose only. Subcutanesously (s.c., under the skin)

Active Comparator: Insulin Aspart Drug: insulin aspart
Subject will receive one single dose only. Subcutanesously (s.c., under the skin)




Primary Outcome Measures :
  1. The number of treatment emergent adverse events [ Time Frame: From the time of dosing (Visit 2,Day 1) and until completion of the post-treatment follow-up visit (Visit 3) i.e. 11−13 days. ]

Secondary Outcome Measures :
  1. Area under the serum NNC0143-0406 concentration-time curve [ Time Frame: From 0 to 24 hours ]
  2. Area under the glucose infusion rate-time curve [ Time Frame: From 0 to 24 hours ]
  3. The maximum glucose infusion rate [ Time Frame: From 0 to 24 hours ]


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:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male, 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
  • Body mass index between 18.5 and 28.0 kg/m^2 (both inclusive)

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 contraceptive, a contraceptive patch, a diaphragm or intrauterine device, together with a physical barrier such as condom. Malesubjects must also agree to refrain from sperm donation from randomisation until 90 days after dosing
  • History or presence of any clinically relevant respiratory, metabolic (including dyslipidaemia), renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus)
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 90 days prior to screening
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the last 180 days

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): NCT02612844


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, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02612844     History of Changes
Other Study ID Numbers: NN1406-4209
2014-005334-63 ( EudraCT Number )
U1111-1164-6630 ( Other Identifier: WHO )
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs