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Completed

NCT Number: NCT01536028

Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart 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–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

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
  • Serum C-peptide maximum 0.4 ng/mL
  • Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine
  • BMI (Body Mass Index) maximum 32 kg/m^2
  • HbA1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory
  • Non-smoker

Exclusion criteria

  • 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/day
  • Current treatment with IAsp (insulin aspart) products
  • A history of drug or alcohol abuse within the last 5 years
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac problems
  • Severe, uncontrolled hypertension

Treatment and study plan

biphasic insulin aspart 30

Drug

A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between

biphasic insulin aspart 50

Drug

A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between

biphasic insulin aspart 70

Drug

A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between

insulin aspart

Drug

A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between

Primary outcomes

  1. Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing

Secondary outcomes

  1. Maximum GIR value

  2. Time to maximum GIR value

  3. Area under the GIR-curves

  4. Maximum drug concentration for insulin aspart (IAsp)

  5. Time to maximum IAsp concentration

  6. Area under the curve of the IAsp profiles

  7. Minimum drug concentration in NEFA (Nonesterified fatty acids)

  8. Time to minimum plasma concentration, NEFA

  9. Area under the curve of the NEFA profiles

  10. Adverse events

  11. Hypoglycaemic episodes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Double-blind, Randomised, Four-Period Crossover Trial Comparing the Pharmacodynamics and Pharmacokinetics After Single Dose of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Insulin Aspart in Subjects With Type 1 Diabetes

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Feb 20, 2012
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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