Within-subject Variability of Insulin Detemir in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01497535
First received: December 20, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.


Condition Intervention Phase
Diabetes
Healthy
Drug: insulin detemir
Drug: insulin glargine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single-centre, Parallel-group, Randomised, Double Blind Trial in Healthy Japanese Subjects Comparing the Within-subject Variability of Insulin Detemir and Insulin Glargine With Respect to Pharmacodynamic and Pharmacokinetic Properties

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Maximum glucose infusion rate (GIRmax) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the glucose infusion rate curve (AUCGIR) [ Designated as safety issue: No ]
  • Time to maximum glucose infusion rate (tGIRmax) [ Designated as safety issue: No ]
  • Area under the insulin concentration curve (AUC) [ Designated as safety issue: No ]
  • Maximum insulin concentration (Cmax) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2004
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin detemir Drug: insulin detemir
On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)
Active Comparator: Insulin glargine Drug: insulin glargine
On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy Japanese men or women
  • Holding a Japanese pass-port and Japanese-born parents
  • Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
  • Body Mass Index (BMI) between 18 and 30 kg/m^2, incl.
  • Fasting blood glucose maximum 6 mmol/L

Exclusion Criteria:

  • Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
  • Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator
  • Subject with history of alcohol or drug dependence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497535

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Yoriko Matsumura Novo Nordisk Pharma Ltd.
Study Director: Lisbeth V. Jacobsen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01497535     History of Changes
Other Study ID Numbers: NN304-1438
Study First Received: December 20, 2011
Last Updated: December 20, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014