A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes

June 18, 2019 updated by: Novo Nordisk A/S
The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children [6-11 years], adolescents [12-17 years] and adults [18-64 years]) who have diabetes. The blood sugar (glucose) lowering effect of faster aspart will also be investigated after consuming a meal replacement drink. The effects of faster aspart will be compared to the effects of NovoRapid®.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30173
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
  • Diagnosed with type 1 diabetes greater than or equal to 12 months prior to the day of screening
  • Body mass index for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults less than or equal to 28.0 kg/sqm

Exclusion Criteria:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
  • Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Faster aspart followed by insulin aspart (NovoRapid®)
Participants will receive single dose of fast-acting insulin aspart followed by single dose of NovoRapid® on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.
Drug: Faster aspart
An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.
Drug: Insulin aspart (NovoRapid®)
An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.
Experimental: Insulin aspart (NovoRapid®) followed by faster aspart
Participants will receive single dose of NovoRapid® followed by single dose of fast-acting insulin aspart on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.
Drug: Faster aspart
An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.
Drug: Insulin aspart (NovoRapid®)
An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
Time Frame: 0-12 hours
Calculated based on insulin aspart measured in blood.
0-12 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes
Time Frame: 0-15 minutes
Calculated based on insulin aspart measured in blood.
0-15 minutes
AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes
Time Frame: 0-30 minutes
Calculated based on insulin aspart measured in blood.
0-30 minutes
AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour
Time Frame: 0-1 hour
Calculated based on insulin aspart measured in blood.
0-1 hour
AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour
Time Frame: 0-1½ hour
Calculated based on insulin aspart measured in blood.
0-1½ hour
AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours
Time Frame: 0-2 hours
Calculated based on insulin aspart measured in blood.
0-2 hours
Cmax,IAsp, maximum observed serum insulin aspart concentration
Time Frame: 0-12 hours
Calculated based on insulin aspart measured in blood.
0-12 hours
tmax,IAsp, time to maximum observed serum insulin aspart concentration
Time Frame: 0-12 hours
Calculated based on insulin aspart measured in blood.
0-12 hours
Onset of appearanceIAsp, time from trial product administration until the first time serum insulinaspart concentration greater than or equal to Lower Limit Of Quantitation (LLOQ)
Time Frame: 0-12 hours
Calculated based on insulin aspart measured in blood.
0-12 hours
Duration of exposureIAsp, time from trial product administration until the first time serum insulin aspart concentration is equal to LLOQ in the terminal part of the curve
Time Frame: 0-12 hours
Calculated based on insulin aspart measured in blood.
0-12 hours
Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp
Time Frame: 0-12 hours
Calculated based on insulin aspart measured in blood.
0-12 hours
Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp
Time Frame: 0-12 hours
Calculated based on insulin aspart measured in blood.
0-12 hours
Mean change in plasma glucose concentration from 0-1 hour after administration
Time Frame: 0-1 hour
Calculated based on glucose concentration measured in plasma.
0-1 hour
Mean change in plasma glucose concentration from 0-2 hours after administration
Time Frame: 0-2 hours
Calculated based on glucose concentration measured in plasma.
0-2 hours
Mean change in plasma glucose concentration from 0-6 hours after administration
Time Frame: 0-6 hours
Calculated based on glucose concentration measured in plasma.
0-6 hours
Change from baseline in plasma glucose concentration 1 hour after administration
Time Frame: Pre-dose (0 hour), 1 hour
Calculated based on glucose concentration measured in plasma.
Pre-dose (0 hour), 1 hour
Change from baseline in plasma glucose concentration 2 hours after administration
Time Frame: Pre-dose (0 hour), 2 hours
Calculated based on glucose concentration measured in plasma.
Pre-dose (0 hour), 2 hours
Plasma glucose concentration 1 hour after administration
Time Frame: 1 hour after administration
Calculated based on glucose concentration measured in plasma.
1 hour after administration
Plasma glucose concentration 2 hours after administration
Time Frame: 2 hours after administration
Calculated based on glucose concentration measured in plasma.
2 hours after administration
Maximum plasma glucose excursion after administration
Time Frame: 0-6 hours
Calculated based on glucose concentration measured in plasma.
0-6 hours
Maximum plasma glucose concentration after administration
Time Frame: 0-6 hours
Calculated based on glucose concentration measured in plasma.
0-6 hours
Time to maximum plasma glucose concentration after administration
Time Frame: 0-6 hours
Calculated based on glucose concentration measured in plasma.
0-6 hours
Minimum plasma glucose concentration after administration
Time Frame: 0-6 hours
Calculated based on glucose concentration measured in plasma.
0-6 hours
Number of adverse events
Time Frame: From screening day 1 up to the study completion day 68
Count of events
From screening day 1 up to the study completion day 68
Number of hypoglycaemic episodes
Time Frame: From screening day 1 up to the study completion day 68
Count of hypoglycaemic episodes
From screening day 1 up to the study completion day 68

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN1218-4371
  • 2017-002014-31 (Registry Identifier: European Medicines Agency (EudraCT))
  • U1111-1197-0428 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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