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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec

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: NCT01865279
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE May 27, 2013
First Posted Date  ICMJE May 30, 2013
Last Update Posted Date October 23, 2015
Study Start Date  ICMJE December 2005
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2013)
  • Frequency of adverse events (trial part 1 only) [ Time Frame: From day prior to dosing and until 10-14 days after dosing ]
  • Area under the glucose infusion rate curve (trial part 2 only) [ Time Frame: 0-24 hours after dosing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01865279 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2013)
Area under the serum insulin concentration curve [ Time Frame: 0-72 hours after dosing ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec
Official Title  ICMJE A Randomised, Double-blind, Placebo-controlled Single Dose, Dose Escalation Trial With Insulin 454 in Healthy Male Subjects, Followed by a Two-period Cross-over Trial With Insulin 454 and Insulatard® in Male Subjects With Type 1 and Type 2 Diabetes Mellitus
Brief Summary This trial is conducted in Europe. The aim of this 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 insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commerical formulation.
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
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: insulin degludec
    Ascending single doses - 5 dose levels. Escalation to next dose level will be performed following evaluation of safety data.
  • Drug: placebo
    Ascending single doses - 5 dose levels
  • Drug: insulin degludec
    A single dose corresponding to that of isophane human insulin
  • Drug: isophane human insulin
    A single dose of 0.4 IU/kg is administered to subjects with type 1 diabetes while a single dose of 0.6 IU/kg is administered to subjects with type 2 diabetes
Study Arms  ICMJE
  • Experimental: Trial part 1
    Interventions:
    • Drug: insulin degludec
    • Drug: placebo
  • Active Comparator: Trial part 2
    Interventions:
    • Drug: insulin degludec
    • Drug: isophane human insulin
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: May 27, 2013)
64
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HEALTHY SUBJECTS:
  • Subjects will be healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
  • Body mass index (BMI) between 18.0-27.0 kg/m^2 (both inclusive)
  • SUBJECTS WITH TYPE 1 AND TYPE 2 DIABETES:
  • Subjects will be male volunteers, who are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
  • Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months or diagnosed with type 2 diabetes mellitus for at least 12 months
  • Body Mass Index (BMI) between 18.0-27.0 kg/m^2 (both inclusive) for subjects with type 1 diabetes or 25.0-35.0 kg/m^2 (both inclusive) for subjects with type 2 diabetes
  • Glycogylated haemoglobin (HbA1c) maximum 8.5 % based on central laboratory results
  • Subjects with type 2 diabetes must have been treated with insulin for the past 3 months prior to screening

Exclusion Criteria:

  • Participation in any other trials involving investigational products within 3 months preceding the start of dosing
  • History of significant multiple drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product, as judged by the investigator
  • Hepatitis or carrier of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies or a positive result to the test for human immunodeficiency (HIV) antibodies
  • Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the investigator
  • Subjects who have donated any blood or plasma in the past month or in excess of 1000 ml within the 12 weeks preceding screening
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01865279
Other Study ID Numbers  ICMJE NN5401-1718
2005-003974-65 ( EudraCT Number )
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, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date October 2015

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