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CompletedNCT02594033Updated Aug 1, 2017

A Trial to Investigate Different Needle Features Assessed by Comparing Insulin Aspart Pharmacokinetic Profiles

A Phase 1 interventional study of insulin aspart in Diabetes, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-01.

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

Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

This trial is conducted in Europe. The aim of the trial is to investigate different needle features assessed by comparing insulin aspart Pharmacokinetics profiles (the exposure of the trial drug in the body)

02

Conditions studied

  • Diabetes

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03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 46 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.

Browse Novo Nordisk A/S studies →

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • Male, age at least 18 years at time of signing informed consent
  • Considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
  • Body mass index (BMI) 28-39.9 kg/m\^2 (overweight to obese)
  • Caucasian

Exclusion criteria

Exclusion Criteria:

  • Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
  • Non-fasting blood glucose test with blood glucose values above 11.1 millimol per liter (mmol/L)
  • HbA1c (Glycosylated Haemoglobin) equal to or above 6.5%
  • Known active or in-active skin disease in the injection area or that could affect pain perception
  • History of deep leg vein thrombosis or repeated episodes of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the investigator
  • Use of any prescription or non-prescription medication, including herbal products and nonroutine vitamins, within the last 2 weeks before screening
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the inpatient period
  • Known or suspected abuse of alcohol (defined as regular intake of more than 14 units weekly for men where 1 unit equals 300 milliliter (mL) of beer, 100 mL of wine, or 25 mL of distilled spirits)
  • Positive result of an alcohol breath test
  • Known or suspected drug/chemical substance abuse within 1 year from screening
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    3 mm needle

    Drug: insulin aspart

  • Experimental
    3.5 mm needle

    Drug: insulin aspart

  • Active comparator
    4 mm needle

    Drug: insulin aspart

Interventions

  • Druginsulin aspart

    All subjects make three intervention visits with at least 5 days between individual intervention visits. At each intervention visit the subject receives one insulin aspart injection with only one type of needle.

06

What researchers measure

Primary outcomes

  1. Area under curve insulin aspart measured in serum

    Time frame: During a maximum of 8 hours

  2. Maximum concentration of insulin aspart measured in serum

    Time frame: During a maximum of 8 hours

07

Study locations

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

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2015 to primary completion in Jan 2016, 3 months.

Of 257 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's 3 months is below that.

Counting every sponsor, half of 339 studies reached it within 9 months; a quarter within 4 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2015
First posted
Nov 2, 2015
StartActual
Oct 27, 2015
Primary completionActual
Jan 28, 2016
CompletionActual
Jan 28, 2016
Last update
Aug 1, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02594033
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Nov 2, 2015
Start date
Oct 27, 2015
Primary completion
Jan 28, 2016
Completion
Jan 28, 2016
Last update
Aug 1, 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 Jul 2017. You cannot join it, but the record below documents what was studied.

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