Skip to main content
OpenTrials
Completed

NCT Number: NCT01707160

Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.

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

Leeds, LS2 9NG, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Non-smokers
  • BMI (body mass index) maximum 27 kg/m^2
  • HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%
  • FBG (fasting blood glucose) maximum 6.0 mmol/L

Treatment and study plan

biphasic insulin aspart 30

Drug

One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

biphasic human insulin 30

Drug

One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

Primary outcomes

  1. Area under the Curve

Secondary outcomes

  1. Maximum insulin concentration (Cmax)

  2. Time to maximum insulin concentration (tmax)

  3. Minimum glucose concentration (Cmin(glu))

  4. Time to minimum glucose concentration (tmin(glu))

  5. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Double-blind 2 Way Crossover Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Insulin X14 30/70 PreMix Compared to Human Insulin 30/70 PreMix in Healthy Volunteers

Important dates

Study start
1995
Primary completion
1995
Study completion
1995
First posted
Oct 16, 2012
Registry last updated
Jan 4, 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.