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Bioequivalence of Two Insulatard® Formulations in Healthy Subjects

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: December 5, 2011
Last updated: April 27, 2015
Last verified: April 2015
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
Drug: isophane human insulin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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


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

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
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Please refer to this study by its identifier: NCT01486901

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

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01486901     History of Changes
Other Study ID Numbers: EX1000-1736
2005-006049-18 ( EudraCT Number )
Study First Received: December 5, 2011
Last Updated: April 27, 2015

Additional relevant MeSH terms:
Insulin, Globin Zinc
Isophane insulin, beef
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017