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

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ClinicalTrials.gov Identifier: NCT01524809
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: biphasic insulin aspart 30 Drug: biphasic insulin aspart 70 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2001
Actual Primary Completion Date : June 2001
Actual Study Completion Date : June 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment period 1 Drug: biphasic insulin aspart 30
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.
Drug: biphasic insulin aspart 70
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.
Experimental: Treatment period 2 Drug: biphasic insulin aspart 30
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.
Drug: biphasic insulin aspart 70
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 Outcome Measures :
  1. Area under the serum insulin curve 6-14 hours after dinner at day 15

Secondary Outcome Measures :
  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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524809


Locations
Denmark
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01524809     History of Changes
Other Study ID Numbers: BIASP-1317
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs