NCT02594033

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2016

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

October 30, 2015

Last Update Submit

July 31, 2017

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

  • Area under curve insulin aspart measured in serum

    During a maximum of 8 hours

  • Maximum concentration of insulin aspart measured in serum

    During a maximum of 8 hours

Study Arms (3)

3 mm needle

EXPERIMENTAL
Drug: insulin aspart

3.5 mm needle

EXPERIMENTAL
Drug: insulin aspart

4 mm needle

ACTIVE COMPARATOR
Drug: insulin aspart

Interventions

insulin aspartDRUG

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.

3 mm needle3.5 mm needle4 mm needle

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 2, 2015

Study Start

October 27, 2015

Primary Completion

January 28, 2016

Study Completion

January 28, 2016

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

DE(1)