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Completed

NCT Number: NCT01524809

Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate steady state pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Århus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes for at least 12 months
  • Currently on a multiple dose insulin regimen
  • HbA1c maximum 12.0%
  • BMI (body mass index) below 35 kg/m^2
  • Able and willing to perform self-blood glucose monitoring (SBGM)

Exclusion criteria

  • Treatment with insulin aspart within the last 14 days prior to this trial
  • The receipt of any investigational drug within the last 30 days prior to this trial
  • Total daily insulin dose at least 1.8 U/kg
  • A history of drug abuse or alcohol dependence within the last 5 years
  • Impaired hepatic function
  • Impaired renal function
  • Blood donation within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
  • Cardiac disease
  • Severe, uncontrolled hypertension

Treatment and study plan

biphasic insulin aspart 30

Drug

Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.

biphasic insulin aspart 70

Drug

Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.

Primary outcomes

  1. Area under the serum insulin curve 6-14 hours after dinner at day 15

Secondary outcomes

  1. Area under the serum insulin curve 6-14 hours after dinner at day 1

  2. Area under the serum insulin curve 0-6 hours after dinner

  3. Area under the curve 0-24 hours

  4. Serum insulin

  5. Apparent t½ (apparent elimination half life)

  6. Cmax, maximum concentration

  7. tmax, time to reach Cmax

  8. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Single-Centre, Randomised, Double-Blind, 2- Period Crossover Trial Investigating the Steady State Pharmacokinetics of Biphasic Insulin Aspart 30 and Biphasic Insulin Aspart 70 in Subjects With Type 1 Diabetes

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Feb 2, 2012
Registry last updated
Jan 5, 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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