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Completed

NCT Number: NCT01530048

Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)

This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.

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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

Novo Nordisk Investigational Site

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Considered to be healthy as judged from vital signs, medical history, ECG (electrocardiogram), laboratory values, and physical examination
  • Body mass index between 18 and 27 kg/m^2 (both inclusive)
  • Non-smoker
  • Fasting blood glucose maximum 6 mmol/L
  • HbA1c below 6.4%

Exclusion criteria

  • Pregnant or breast-feeding women
  • Women not using acceptable methods of contraception without difficulties for at least three months prior to trial start (screening), including intrauterine devices, oral contraceptives, hormonal implants, or sterilisation
  • Clinically significant abnormal laboratory values (as judged by the Investigator)
  • Close relative with type 1 diabetes mellitus (father, mother, sister or brother)
  • Intake of alcohol within the last 24 hours prior to screening and drug administration visits
  • Blood donation or blood loss of more than 500 mL within the 3 last months before screening
  • Strenuous exercise within 48 hours before screening as well as drug administration and followup
  • Smoking during the past month before drug administration

Treatment and study plan

insulin aspart

Drug

A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between

Primary outcomes

  1. Area under the curve (AUC) in the interval of 0-6 hours

  2. Cmax, maximum concentration

Secondary outcomes

  1. AUC in the interval of 0-infinity hours

  2. tmax, time to reach Cmax

  3. Terminal rate constant

  4. Vz/f, volume of distribution during terminal phase

  5. t½, terminal half-life

  6. AUCGIR, area under the glucose infusion rate value curve

  7. GIRmax, maximum glucose infusion rate value

  8. tGIRmax, time to maximum glucose infusion rate value

  9. 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 Trial, Assessing the Bioequivalence Between Insulin Aspart 100 U/mL and Insulin Aspart 200 U/mL in Healthy Individuals

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Feb 9, 2012
Registry last updated
Oct 17, 2016

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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