CClinicalTrials.gg
CompletedNCT01620424Updated Jan 5, 2017

Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes

A Phase 1 interventional study of biphasic insulin aspart 30 and biphasic insulin aspart 50 in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Japan. Open to participants aged 20 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
10
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30 (NN-X14Mix30) and biphasic insulin aspart 50 (NN-X14Mix5050) 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 10 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
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetes
  • Duration of diabetes for at least 1 year
  • Body Mass Index (BMI) maximum 30.0 kg/m\^2
  • HbA1c maximum 10.0%

Exclusion criteria

Exclusion Criteria:

  • Recurrent severe hypoglycaemia
  • Proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac problems
  • Uncontrolled treated / untreated hypertension
  • Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
  • Total daily insulin dose exceeding 40 IU
  • Treatment with OHAs (oral hypoglycaemic agents) or insulin preparations twice or more frequently a day
  • Treatment with OHAs or insulin preparations once a day later than noon
  • Subjects who smoke more than 15 cigarettes per day
05

Study design

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

Study arms

  • Experimental
    Dosing visit 1

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

  • Experimental
    Dosing visit 2

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

Interventions

  • Drugbiphasic insulin aspart 30

    Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits

  • Drugbiphasic insulin aspart 50

    Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits

06

What researchers measure

Primary outcomes

  1. The maximum insulin aspart concentration

Secondary outcomes

  1. The area under the insulin aspart curve

  2. tmax, the time to maximum insulin aspart concentration

  3. t½, terminal half-life

  4. The area under the glucose infusion rate (GIR) profile

  5. GIRmax, maximum glucose infusion rate value

  6. tmaxGIR, time to maximum glucose infusion rate value

  7. The area under the glucose infusion rate profile

  8. Vital signs (blood pressure and pulse)

  9. Adverse events

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Tokyo, 1000005, Japan
08

References and documents

Publications

  • Tibaldi JT. Biphasic insulin aspart 70/30 three times a day in older patients with type 2 diabetes not achieving optimal glycemic control on a twice-daily regimen: a retrospective case series analysis from clinical practice. Adv Ther. 2007 Nov-Dec;24(6):1348-56. doi: 10.1007/BF02877782. PubMed 18165218 ↗
  • Hirao K, Maeda H, Urata S, Takisawa Y, Hirao S, Sasako T, Sasaki T. Comparison of the pharmacokinetic and pharmacodynamic profiles of biphasic insulin aspart 50 and 30 in patients with type 2 diabetes mellitus: a single-center, randomized, double-blind, two-period, crossover trial in Japan. Clin Ther. 2007 May;29(5):927-934. doi: 10.1016/j.clinthera.2007.05.017. PubMed 17697911 ↗
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
NCT01620424
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jun 15, 2012
Start date
Feb 2001
Primary completion
Apr 2001
Completion
Apr 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.

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