Back to resultsA Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Faster Aspart 200 U/mL
Faster aspart 100 U/mL
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
- Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion greater than or equal to 1 year prior to the day of screening
Exclusion Criteria:
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening in this trial
- Blood donation, plasma donation or blood draw, defined as any of the below: In excess of 400 mL within the past 90 days prior to the day of screening OR In excess of 50 mL within the past 30 days prior to the day of screening
- Use of tobacco and nicotine products, defined as any of the below: Smoking more than 1 cigarette or the equivalent per day OR Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house periods
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Group D
Group E
Group F
Arm Description
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation D, faster aspart 100 U/mL, formulation B, formulation A, formulation C, formulation E. The dosing visits will be separated by wash-out periods (2-21 days).
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation C, formulation B, formulation D, formulation E, formulation A, faster aspart 100 U/mL. The dosing visits will be separated by wash-out periods (2-21 days).
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation E, formulation C, formulation A, formulation B, faster aspart 100 U/mL, formulation D. The dosing visits will be separated by wash-out periods (2-21 days).
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation A, formulation D, formulation C, faster aspart 100 U/mL, formulation E, formulation B. The dosing visits will be separated by wash-out periods (2-21 days).
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: faster aspart 100 U/mL, formulation A, formulation E, formulation D, formulation B, formulation C. The dosing visits will be separated by wash-out periods (2-21 days).
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation B, formulation E, faster aspart 100 U/mL, formulation C, formulation D, formulation A. The dosing visits will be separated by wash-out periods (2-21 days).
Outcomes
Primary Outcome Measures
AUCIAsp,0h-t - Area under the serum insulin aspart concentration-time curve from 0 to t hours after investigational medicinal product (IMP) administration, where t is end of exposure
Measured in pmol*h/L
Secondary Outcome Measures
AUCIAsp,0-1h - Area under the serum insulin aspart concentration-time curve from 0 to 1 hour after IMP administration
Measured in pmol*h/L
AUCIAsp,0-2h - Area under the serum insulin aspart concentration-time curve from 0 to 2 hours after IMP administration
Measured in pmol*h/L
AUCIAsp,0-inf - Area under the serum insulin aspart concentration-time curve from 0 hours after IMP administration to infinity
Measured in pmol*h/L
Cmax,IAsp - Maximum observed serum insulin aspart concentration
Measured in pmol/L
tmax,IAsp - Time to maximum observed serum insulin aspart concentration
Measured in minutes
Number of adverse events in the treatment emergent period
Count of events
Number of local reactions at the injection site in the treatment emergent period
Count of injection site reactions
Number of hypoglycaemic episodes in the treatment emergent period
Count of hypoglycaemic episodes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03723759
Brief Title
A Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes Mellitus
Official Title
A Trial Investigating the Pharmacokinetic Properties of Five Formulations of Fast-acting Insulin Aspart 200 U/mL in Subjects With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 26, 2018 (Actual)
Primary Completion Date
March 21, 2019 (Actual)
Study Completion Date
March 27, 2019 (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
This study is looking at how five different formulations of faster aspart 200 U/mL reach and stay in the blood after injection. The purpose is to find a formulation that behaves similarly to the reference product called faster aspart 100 U/mL (marketed as Fiasp®). The participant will get all five formulations and the reference product. The order in which the participant gets them is decided by chance. The participant will get each medicine once during the study meaning that the participant will get a total of six injections with study medicine. The medicine will be injected under the skin in the stomach. The study will last for about 2 to 21 weeks depending on individual visit schedule. The participant will have nine clinic visits with the study doctor (including the one in which the participant give consent).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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 asked according to company standard procedures
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation D, faster aspart 100 U/mL, formulation B, formulation A, formulation C, formulation E.
The dosing visits will be separated by wash-out periods (2-21 days).
Arm Title
Group B
Arm Type
Experimental
Arm Description
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation C, formulation B, formulation D, formulation E, formulation A, faster aspart 100 U/mL.
The dosing visits will be separated by wash-out periods (2-21 days).
Arm Title
Group C
Arm Type
Experimental
Arm Description
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation E, formulation C, formulation A, formulation B, faster aspart 100 U/mL, formulation D.
The dosing visits will be separated by wash-out periods (2-21 days).
Arm Title
Group D
Arm Type
Experimental
Arm Description
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation A, formulation D, formulation C, faster aspart 100 U/mL, formulation E, formulation B.
The dosing visits will be separated by wash-out periods (2-21 days).
Arm Title
Group E
Arm Type
Experimental
Arm Description
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
faster aspart 100 U/mL, formulation A, formulation E, formulation D, formulation B, formulation C.
The dosing visits will be separated by wash-out periods (2-21 days).
Arm Title
Group F
Arm Type
Experimental
Arm Description
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation B, formulation E, faster aspart 100 U/mL, formulation C, formulation D, formulation A.
The dosing visits will be separated by wash-out periods (2-21 days).
Intervention Type
Drug
Intervention Name(s)
Faster Aspart 200 U/mL
Intervention Description
A single dose (0.15 U/kg) of five formulations of fast-acting insulin aspart 200 U/mL (formulations A, B, C, D, E) in a sequential manner via subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Faster aspart 100 U/mL
Intervention Description
A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.
Primary Outcome Measure Information:
Title
AUCIAsp,0h-t - Area under the serum insulin aspart concentration-time curve from 0 to t hours after investigational medicinal product (IMP) administration, where t is end of exposure
Description
Measured in pmol*h/L
Time Frame
0 to 10 hours after IMP administration
Secondary Outcome Measure Information:
Title
AUCIAsp,0-1h - Area under the serum insulin aspart concentration-time curve from 0 to 1 hour after IMP administration
Description
Measured in pmol*h/L
Time Frame
0 to 1 hour after IMP administration
Title
AUCIAsp,0-2h - Area under the serum insulin aspart concentration-time curve from 0 to 2 hours after IMP administration
Description
Measured in pmol*h/L
Time Frame
0 to 2 hours after IMP administration
Title
AUCIAsp,0-inf - Area under the serum insulin aspart concentration-time curve from 0 hours after IMP administration to infinity
Description
Measured in pmol*h/L
Time Frame
0 to 10 hours after IMP administration
Title
Cmax,IAsp - Maximum observed serum insulin aspart concentration
Description
Measured in pmol/L
Time Frame
0 to 10 hours after IMP administration
Title
tmax,IAsp - Time to maximum observed serum insulin aspart concentration
Description
Measured in minutes
Time Frame
0 to 10 hours after IMP administration
Title
Number of adverse events in the treatment emergent period
Description
Count of events
Time Frame
0 to 2 days after IMP administration
Title
Number of local reactions at the injection site in the treatment emergent period
Description
Count of injection site reactions
Time Frame
0 to 2 days after IMP administration
Title
Number of hypoglycaemic episodes in the treatment emergent period
Description
Count of hypoglycaemic episodes
Time Frame
0 to 16 hours after IMP administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening
Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion greater than or equal to 1 year prior to the day of screening
Exclusion Criteria:
Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening in this trial
Blood donation, plasma donation or blood draw, defined as any of the below: In excess of 400 mL within the past 90 days prior to the day of screening OR In excess of 50 mL within the past 30 days prior to the day of screening
Use of tobacco and nicotine products, defined as any of the below: Smoking more than 1 cigarette or the equivalent per day OR Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house periods
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
Neuss
ZIP/Postal Code
41460
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 Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes Mellitus
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