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CompletedNCT01526941Updated Jan 5, 2017

Comparison of Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes

A Phase 1 interventional study of biphasic insulin aspart 30 and biphasic insulin aspart 70 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 and older. Per ClinicalTrials.gov, last updated 2017-01-05.

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

Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This trial is conducted in Europe. The aim of this trial is to compare the single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 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 27 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 and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 1 diabetes for at least 12 months
  • Currently on basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily
  • BMI (Body Mass Index) maximum 35 kg/m\^2
  • Able and willing to perform self-blood glucose monitoring

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
  • Currently being treated with insulin aspart products
  • A history of drug abuse or alcohol dependence within the last 5 years
  • Impaired hepatic function
  • Impaired renal function
  • Blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
  • Cardiac problems
  • Severe, uncontrolled hypertension
05

Study design

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

Study arms

  • Experimental
    Treatment period 1

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

  • Experimental
    Treatment period 2

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

Interventions

  • Drugbiphasic insulin aspart 30

    Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods

  • Drugbiphasic insulin aspart 70

    Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods

06

What researchers measure

Primary outcomes

  1. Steady state area under the glucose infusion rate profile, 6-12 hours

Secondary outcomes

  1. GIRmax, the maximal glucose infusion rate value

  2. tmax, time to maximum glucose infusion rate value

  3. area under the glucose infusion rate profile

  4. Time to 50% of area under the glucose infusion rate profile, 0-12 hours

  5. Cmax, maximum concentration

  6. tmax, time to reach Cmax

  7. Area under the curve

  8. t½, terminal half-life

  9. Adverse events

07

Study locations

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

References and documents

Publications

  • Bott S, Tusek C, Heinemann L, Friberg HH, Heise T. The pharmacokinetic and pharmacodynamic properties of biphasic insulin Aspart 70 (BIAsp 70) are significantly different from those of biphasic insulin Aspart 30 (BIAsp 30). Exp Clin Endocrinol Diabetes. 2005 Oct;113(9):545-50. doi: 10.1055/s-2005-872852. PubMed 16235159 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01526941
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Feb 6, 2012
Start date
May 2001
Primary completion
Jul 2001
Completion
Jul 2001
Last update
Jan 5, 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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