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Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Characteristics of Explorative Formulations of Insulin Degludec and IDegAsp 50 in Healthy Japanese Subjects

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ClinicalTrials.gov Identifier: NCT01865331
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : January 15, 2016
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 safety, tolerability and pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM), both explorative formulations, not similar to the proposed commercial formulation, in healthy male Japanese subjects.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: insulin degludec Drug: placebo Drug: insulin degludec/insulin aspart 50 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Single-dose, Parallel Group Trial With Insulin 454 and SIAM 50 in Healthy Male Japanese Subjects
Study Start Date : December 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low dose, insulin degludec Drug: insulin degludec
Single dose administered subcutaneously (s.c., under the skin).

Drug: placebo
Administered subcutaneously (s.c., under the skin)

Experimental: Medium dose, insulin degludec Drug: insulin degludec
Single dose administered subcutaneously (s.c., under the skin).

Drug: placebo
Administered subcutaneously (s.c., under the skin)

Experimental: High dose, insulin degludec Drug: insulin degludec
Single dose administered subcutaneously (s.c., under the skin).

Drug: placebo
Administered subcutaneously (s.c., under the skin)

Experimental: IDegAsp 50 Drug: placebo
Administered subcutaneously (s.c., under the skin)

Drug: insulin degludec/insulin aspart 50
Single dose of IDegAsp 50 administered subcutaneously (s.c., under the skin)




Primary Outcome Measures :
  1. Frequency of adverse events (AEs) [ Time Frame: From dosing visit and until follow-up 7-21 days after last dosing visit ]

Secondary Outcome Measures :
  1. Area under the serum insulin concentration curve [ Time Frame: 0-96 hours after dosing ]
  2. Area under the glucose infusion rate curve [ Time Frame: 0-24 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:

  • Japanese passport holder
  • Japanese-born parents
  • Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
  • Fasting blood glucose of below or equal to 6 mmol/L
  • Healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data at screening, as assessment of medical history, physical exjudged by the Investigator

Exclusion Criteria:

  • The receipt of any investigational drug within 3 months prior to this trial
  • Subjects with a history of significant multiple drug allergies or with a known allergy to the trialproduct or any medicine chemically related to the trial product, as judged by the Investigator

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): NCT01865331


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: NCT01865331     History of Changes
Other Study ID Numbers: NN5401-1788
2006-002615-26 ( EudraCT Number )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs