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

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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

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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin degludec Drug: placebo Drug: isophane human insulin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Trial part 1 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

Active Comparator: Trial part 2 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




Primary Outcome Measures :
  1. Frequency of adverse events (trial part 1 only) [ Time Frame: From day prior to dosing and until 10-14 days after dosing ]
  2. Area under the glucose infusion rate curve (trial part 2 only) [ Time Frame: 0-24 hours after dosing ]

Secondary Outcome Measures :
  1. Area under the serum insulin concentration curve [ Time Frame: 0-72 hours after dosing ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01865279


Locations
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Germany
Neuss, Germany, 41460
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: NCT01865279     History of Changes
Other Study ID Numbers: NN5401-1718
2005-003974-65 ( EudraCT Number )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: October 23, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Isophane Insulin, Human
Insulin, Isophane
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs