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Bioequivalence of Two Insulatard® Formulations in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01486901
First Posted: December 7, 2011
Last Update Posted: April 28, 2015
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.

Condition Intervention Phase
Diabetes Healthy Drug: isophane human insulin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulatard® (600 Nmol/ml) and Insulatard® (1998 Nmol/ml) in Healthy Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the serum insulin concentration-time curve (AUC 0-24 hours)
  • Maximum serum insulin concentration (Cmax)

Secondary Outcome Measures:
  • Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)
  • Time to maximum serum insulin concentration (tmax)
  • Terminal serum insulin half life (t½)
  • Adverse events

Enrollment: 44
Study Start Date: May 2006
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation A Drug: isophane human insulin
Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
Active Comparator: Formulation B Drug: isophane human insulin
Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
  • Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2, inclusive
  • Non-smoker, defined as no nicotine consumption for at least one year
  • Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)

Exclusion Criteria:

  • Previous participation in this trial or other clinical trials within the last 3 months
  • Body weight above 87.5 kg
  • Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilisation, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant)
  • History of alcohol or drug abuse
  Contacts and Locations
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): NCT01486901


Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01486901     History of Changes
Other Study ID Numbers: EX1000-1736
2005-006049-18 ( EudraCT Number )
First Submitted: December 5, 2011
First Posted: December 7, 2011
Last Update Posted: April 28, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs