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Completed

NCT Number: NCT01487811

Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers

This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.

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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–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI (body mass index) between 18 and 28 kg/m^2, both inclusive
  • Subject is a nonsmoker for at least 3 months
  • Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
  • Fasting plasma glucose between 80 and 110 mg/dl

Exclusion criteria

  • •Any clinically significant disease history of systemic or organ disease
  • •Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
  • •In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative

Treatment and study plan

biphasic insulin aspart 30

Drug

Single dose administrated subcutaneously (s.c., under the skin)

Primary outcomes

  1. Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity

  2. Maximum drug concentration of the two formulations (Cmax)

Secondary outcomes

  1. Area under the concentration curve for insulin aspart from time 0 hours to 16 hours

  2. Mean residence time (MRT)

  3. Frequency of adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Bioequivalence of Two Biphasic Insulin Aspart 30 (NovoLog® Mix 70/30) Formulations (Current and New Formulation With Glycerol): A Randomized, Double-Blind, Two-Period Crossover Study in Healthy Volunteers

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Dec 7, 2011
Registry last updated
Jan 6, 2017

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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