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Bioequivalence of Two Insulatard® Formulations in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01486901
First received: December 5, 2011
Last updated: April 27, 2015
Last verified: April 2015

December 5, 2011
April 27, 2015
May 2006
July 2006   (final data collection date for primary outcome measure)
  • Area under the serum insulin concentration-time curve (AUC 0-24 hours) [ Designated as safety issue: No ]
  • Maximum serum insulin concentration (Cmax) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01486901 on ClinicalTrials.gov Archive Site
  • Area under the serum insulin concentration-time curve (AUC 0-inifinity hours) [ Designated as safety issue: No ]
  • Time to maximum serum insulin concentration (tmax) [ Designated as safety issue: No ]
  • Terminal serum insulin half life (t½) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bioequivalence of Two Insulatard® Formulations in Healthy Subjects
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
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Healthy
Drug: isophane human insulin
Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
  • Experimental: Formulation A
    Intervention: Drug: isophane human insulin
  • Active Comparator: Formulation B
    Intervention: Drug: isophane human insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01486901
EX1000-1736, 2005-006049-18
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP