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CompletedNCT01536028Updated Jan 6, 2017

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

A Phase 1 interventional study of biphasic insulin aspart 30 and biphasic insulin aspart 50 in Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-01-06.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 32 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    BIAsp 30

    Drug: biphasic insulin aspart 30 · Drug: biphasic insulin aspart 50 · Drug: biphasic insulin aspart 70 · Drug: insulin aspart

  • Experimental
    BIAsp 50

    Drug: biphasic insulin aspart 30 · Drug: biphasic insulin aspart 50 · Drug: biphasic insulin aspart 70 · Drug: insulin aspart

  • Experimental
    BIAsp 70

    Drug: biphasic insulin aspart 30 · Drug: biphasic insulin aspart 50 · Drug: biphasic insulin aspart 70 · Drug: insulin aspart

  • Active comparator
    IAsp

    Drug: biphasic insulin aspart 30 · Drug: biphasic insulin aspart 50 · Drug: biphasic insulin aspart 70 · Drug: insulin aspart

Interventions

  • Drugbiphasic insulin aspart 30

    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

  • Drugbiphasic insulin aspart 50

    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

  • Drugbiphasic insulin aspart 70

    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

  • Druginsulin aspart

    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

06

What researchers measure

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

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Neuss, 41460, Germany
08

References and documents

Publications

  • Heise T, Eckers U, Kanc K, Nielsen JN, Nosek L. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: a randomized, glucose clamp, crossover study. Diabetes Technol Ther. 2008 Dec;10(6):479-85. doi: 10.1089/dia.2008.0019. PubMed 19049377 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01536028
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Feb 20, 2012
Start date
Apr 2006
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Jan 6, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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