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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 17, 2016
First Posted Date  ICMJE October 19, 2016
Last Update Posted Date February 26, 2018
Actual Study Start Date  ICMJE October 19, 2016
Actual Primary Completion Date June 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
The ratio of suppression of endogenous glucose production relative to total glucose lowering effect [ Time Frame: Two weeks of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02938572 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2017)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
Number of treatment emergent adverse events [ Time Frame: Time of first trial product administration to 7 days (7 times 24 hours) after trial product administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomised Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus
Official Title  ICMJE Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: NNC0143-0406
    Administered subcutaneously (s.c. under the skin)
  • Drug: Insulin Aspart
    Administered subcutaneously (s.c. under the skin)
Study Arms  ICMJE
  • Experimental: NNC0143-0406
    Intervention: Drug: NNC0143-0406
  • Active Comparator: Insulin aspart
    Intervention: Drug: Insulin Aspart
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2017)
47
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2016)
44
Actual Study Completion Date  ICMJE July 4, 2017
Actual Primary Completion Date June 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02938572
Other Study ID Numbers  ICMJE NN1406-4218
2014-005340-18 ( EudraCT Number )
U1111-1164-6715 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP