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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014