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Completed

NCT Number: NCT01486888

Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biphasic human insulin 30

Drug

Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits

Primary outcomes

  1. Area under the serum insulin concentration-time curve (AUC 0-24 hours)

  2. Maximum serum insulin concentration (Cmax)

Secondary outcomes

  1. Area under the serum insulin concentration-time curve (AUC 0-6 hours)

  2. Area under the serum insulin concentration-time curve (AUC 6-24 hours)

  3. Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)

  4. Time to maximum serum insulin concentration (tmax)

  5. Terminal insulin half life (t½)

  6. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Dec 7, 2011
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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