Back to resultsA Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Faster aspart
Insulin aspart (NovoRapid®)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Faster aspart followed by insulin aspart (NovoRapid®)
Insulin aspart (NovoRapid®) followed by faster aspart
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
Calculated based on insulin aspart measured in blood.
Secondary Outcome Measures
AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes
Calculated based on insulin aspart measured in blood.
AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes
Calculated based on insulin aspart measured in blood.
AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour
Calculated based on insulin aspart measured in blood.
AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour
Calculated based on insulin aspart measured in blood.
AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours
Calculated based on insulin aspart measured in blood.
Cmax,IAsp, maximum observed serum insulin aspart concentration
Calculated based on insulin aspart measured in blood.
tmax,IAsp, time to maximum observed serum insulin aspart concentration
Calculated based on insulin aspart measured in blood.
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)
Calculated based on insulin aspart measured in blood.
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
Calculated based on insulin aspart measured in blood.
Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp
Calculated based on insulin aspart measured in blood.
Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp
Calculated based on insulin aspart measured in blood.
Mean change in plasma glucose concentration from 0-1 hour after administration
Calculated based on glucose concentration measured in plasma.
Mean change in plasma glucose concentration from 0-2 hours after administration
Calculated based on glucose concentration measured in plasma.
Mean change in plasma glucose concentration from 0-6 hours after administration
Calculated based on glucose concentration measured in plasma.
Change from baseline in plasma glucose concentration 1 hour after administration
Calculated based on glucose concentration measured in plasma.
Change from baseline in plasma glucose concentration 2 hours after administration
Calculated based on glucose concentration measured in plasma.
Plasma glucose concentration 1 hour after administration
Calculated based on glucose concentration measured in plasma.
Plasma glucose concentration 2 hours after administration
Calculated based on glucose concentration measured in plasma.
Maximum plasma glucose excursion after administration
Calculated based on glucose concentration measured in plasma.
Maximum plasma glucose concentration after administration
Calculated based on glucose concentration measured in plasma.
Time to maximum plasma glucose concentration after administration
Calculated based on glucose concentration measured in plasma.
Minimum plasma glucose concentration after administration
Calculated based on glucose concentration measured in plasma.
Number of adverse events
Count of events
Number of hypoglycaemic episodes
Count of hypoglycaemic episodes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03407599
Brief Title
A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
Official Title
A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
July 5, 2018 (Actual)
Study Completion Date
July 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Faster aspart followed by insulin aspart (NovoRapid®)
Arm Type
Experimental
Arm Description
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.
Arm Title
Insulin aspart (NovoRapid®) followed by faster aspart
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Faster aspart
Intervention Description
An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.
Intervention Type
Drug
Intervention Name(s)
Insulin aspart (NovoRapid®)
Intervention Description
An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.
Primary Outcome Measure Information:
Title
AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
Description
Calculated based on insulin aspart measured in blood.
Time Frame
0-12 hours
Secondary Outcome Measure Information:
Title
AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes
Description
Calculated based on insulin aspart measured in blood.
Time Frame
0-15 minutes
Title
AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes
Description
Calculated based on insulin aspart measured in blood.
Time Frame
0-30 minutes
Title
AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour
Description
Calculated based on insulin aspart measured in blood.
Time Frame
0-1 hour
Title
AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour
Description
Calculated based on insulin aspart measured in blood.
Time Frame
0-1½ hour
Title
AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours
Description
Calculated based on insulin aspart measured in blood.
Time Frame
0-2 hours
Title
Cmax,IAsp, maximum observed serum insulin aspart concentration
Description
Calculated based on insulin aspart measured in blood.
Time Frame
0-12 hours
Title
tmax,IAsp, time to maximum observed serum insulin aspart concentration
Description
Calculated based on insulin aspart measured in blood.
Time Frame
0-12 hours
Title
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)
Description
Calculated based on insulin aspart measured in blood.
Time Frame
0-12 hours
Title
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
Description
Calculated based on insulin aspart measured in blood.
Time Frame
0-12 hours
Title
Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp
Description
Calculated based on insulin aspart measured in blood.
Time Frame
0-12 hours
Title
Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp
Description
Calculated based on insulin aspart measured in blood.
Time Frame
0-12 hours
Title
Mean change in plasma glucose concentration from 0-1 hour after administration
Description
Calculated based on glucose concentration measured in plasma.
Time Frame
0-1 hour
Title
Mean change in plasma glucose concentration from 0-2 hours after administration
Description
Calculated based on glucose concentration measured in plasma.
Time Frame
0-2 hours
Title
Mean change in plasma glucose concentration from 0-6 hours after administration
Description
Calculated based on glucose concentration measured in plasma.
Time Frame
0-6 hours
Title
Change from baseline in plasma glucose concentration 1 hour after administration
Description
Calculated based on glucose concentration measured in plasma.
Time Frame
Pre-dose (0 hour), 1 hour
Title
Change from baseline in plasma glucose concentration 2 hours after administration
Description
Calculated based on glucose concentration measured in plasma.
Time Frame
Pre-dose (0 hour), 2 hours
Title
Plasma glucose concentration 1 hour after administration
Description
Calculated based on glucose concentration measured in plasma.
Time Frame
1 hour after administration
Title
Plasma glucose concentration 2 hours after administration
Description
Calculated based on glucose concentration measured in plasma.
Time Frame
2 hours after administration
Title
Maximum plasma glucose excursion after administration
Description
Calculated based on glucose concentration measured in plasma.
Time Frame
0-6 hours
Title
Maximum plasma glucose concentration after administration
Description
Calculated based on glucose concentration measured in plasma.
Time Frame
0-6 hours
Title
Time to maximum plasma glucose concentration after administration
Description
Calculated based on glucose concentration measured in plasma.
Time Frame
0-6 hours
Title
Minimum plasma glucose concentration after administration
Description
Calculated based on glucose concentration measured in plasma.
Time Frame
0-6 hours
Title
Number of adverse events
Description
Count of events
Time Frame
From screening day 1 up to the study completion day 68
Title
Number of hypoglycaemic episodes
Description
Count of hypoglycaemic episodes
Time Frame
From screening day 1 up to the study completion day 68
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor and Disclosure (1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Hannover
ZIP/Postal Code
30173
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com
Learn more about this trial
A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
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