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
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: 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 July 29, 2014