Skip to main content
OpenTrials
Completed

NCT Number: NCT01698697

Comparison of Two Insulin Aspart Formulations in Healthy Volunteers

This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Bloemfontein, 9324, South Africa

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
  • Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant
  • Body mass index (BMI) 18-26 kg/m^2 (both inclusive)
  • Weight 60-90 kg
  • Non-smoker

Exclusion criteria

  • Any condition requiring the regular use of any medication
  • Known or suspected allergy to the trial product or related products
  • Family history of type 1 diabetes mellitus

Treatment and study plan

insulin aspart

Drug

Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion

Primary outcomes

  1. Area under the curve (AUC)

  2. Area under the glucose infusion rate curve

Secondary outcomes

  1. Cmax (maximum plasma concentration)

  2. Time to reach maximum (tmax)

  3. Terminal half-life (t½)

  4. Incidence of hypoglycemic events

  5. Adverse events

  6. GIRmax: The maximal GIR (glucose infusion rate)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Single Centre, Randomized, Balanced Double-blind, Cross-Over Trial Investigating the Bioequivalence of a Continuous Subcutaneous Infusion of a Marketed NovoRapid Formulation Containing 100 U/ml and a New NovoRapid Formulation Containing 200 U/ml in Healthy Male Volunteers

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Oct 3, 2012
Registry last updated
Mar 1, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.