CClinicalTrials.gg
CompletedNCT01697618Updated Jan 4, 2017

Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes

A Phase 2 interventional study of biphasic insulin aspart 30 and biphasic human insulin 30 in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 2 sites in 2 countries. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-01-04.

Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
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 13 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
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Type 2 diabetes for at least 12 months
  • Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months
  • BMI (body mass index) below 39 kg/m\^2
  • HbA1c (glycosylated haemoglobin) below 12%
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    BIAsp 30

    Drug: biphasic insulin aspart 30 · Drug: biphasic human insulin 30

  • Active comparator
    BHI 30

    Drug: biphasic insulin aspart 30 · Drug: biphasic human insulin 30

Interventions

  • Drugbiphasic insulin aspart 30

    Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs

  • Drugbiphasic human insulin 30

    Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs

06

What researchers measure

Primary outcomes

  1. Area under the serum insulin curve

Secondary outcomes

  1. Overall shape of the 24 hour serum insulin profile

  2. Cmax (maximum plasma concentration)

  3. tmax (time to reach maximum)

  4. Area under the curve following each injections derived from 24 hours serum insulin profiles

  5. Overall shape of the 24 hour serum glucose profile

  6. Serum glucose excursions (EXC)

07

Study locations

2 sites
  • Novo Nordisk Investigational Site
    Alphen a/d Rijn, Netherlands
  • Novo Nordisk Investigational Site
    Crawley, RH11 9RT, United Kingdom
08

References and documents

Publications

  • McSorley PT, Bell PM, Jacobsen LV, Kristensen A, Lindholm A. Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clin Ther. 2002 Apr;24(4):530-9. doi: 10.1016/s0149-2918(02)85129-3. PubMed 12017398 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01697618
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Oct 2, 2012
Start date
Apr 1997
Primary completion
Nov 1998
Completion
Nov 1998
Last update
Jan 4, 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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion