Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01486888
First received: December 5, 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 to test for bioequivalence between two formulations of Mixtard® 30 in healthy subjects.


Condition Intervention Phase
Diabetes
Healthy
Drug: biphasic human insulin 30
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulin Mixtard® 30 (600 Nmol/ml) and Insulin Mixtard® 30 (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) [ Designated as safety issue: No ]
  • Maximum serum insulin concentration (Cmax) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the serum insulin concentration-time curve (AUC 0-6 hours) [ Designated as safety issue: No ]
  • Area under the serum insulin concentration-time curve (AUC 6-24 hours) [ Designated as safety issue: No ]
  • 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 insulin half life (t½) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 45
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: biphasic human insulin 30
Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
Active Comparator: Formulation B Drug: biphasic human insulin 30
Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  • History of alcohol or drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486888

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Jan Lynge 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: NCT01486888     History of Changes
Other Study ID Numbers: EX1000-1735, 2005-006050-24
Study First Received: December 5, 2011
Last Updated: December 5, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014