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A Research Study to Look at How Faster Aspart Works in Chinese People With Type 1 Diabetes or Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Faster Aspart
Novo Rapid
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

For a subject with type 1 diabetes mellitus:

  • Male or female Chinese subjects aged 18-64 years (both inclusive) at the time of signing informed consent.
  • Type 1 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening.
  • Treated with multiple daily insulin injections or premix insulin greater than or equal to 12 months prior to the day of screening or treated with continuous subcutaneous insulin infusion (CSII) greater than or equal to 3 months prior to the day of screening.
  • Glycosylated haemoglobin (HbA1c) less than or equal to 9.0 percent (75 mmol/mol) by central laboratory analysis.

For a subject with type 2 diabetes mellitus:

  • Male or female Chinese subjects aged 18-75 years (both inclusive) at the time of signing informed consent.
  • Type 2 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening.
  • Treated with multiple daily insulin injections or premix insulin greater than or equal to 6 months prior to the day of screening or treated with continuous subcutaneous insulin infusion (CSII) greater than or equal to 3 months prior to the day of screening.
  • Glycosylated haemoglobin less than or equal to 9.5 percent (80 mmol/mol) by central laboratory analysis.

Exclusion criteria:

For a subject with type 1 diabetes mellitus or type 2 diabetes mellitus:

  • Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
  • Surgery or trauma with significant blood loss (more than 400 mL) within the last 3 months prior to screening.
  • Not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period.

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Faster aspart

NovoRapid®

Arm Description

Subjects will receive 2 injections of a single dose of faster aspart at a predefined fixed dose level (0.2 U/kg body weight) for type 1 diabetes and (0.3 U/kg body weight) if subject has type 2 diabetes.

Subjects will receive 2 injections of a single dose of NovoRapid® at a predefined fixed dose level (0.2 U/kg body weight) for type 1 diabetes and (0.3 U/kg body weight) if subject has type 2 diabetes.

Outcomes

Primary Outcome Measures

AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes
pmol·h/L

Secondary Outcome Measures

AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve from 0 to 15 minutes
pmol·h/L
AUCIAsp,0-1h, area under the serum insulin aspart concentration-time curve from 0 to 1 hour
pmol·h/L
AUCIAsp,0-1½h, area under the serum insulin aspart concentration-time curve from 0 to 1½ hours
pmol·h/L
AUCIAsp,0-2h, area under the serum insulin aspart concentration-time curve from 0 to 2 hours
pmol·h/L
AUCIAsp,0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
pmol·h/L
Cmax,IAsp, maximum observed serum insulin aspart concentration
pmol/L
tmax,IAsp, time to maximum observed serum insulin aspart concentration
Minutes
Onset of appearanceIAsp, time from trial product administration until the first time serum insulin aspart concentration greater than or equal to lower limit of quantification (LLOQ)
Minutes
Time to 50 percent Cmax, IAsp, the first time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp
Minutes
Time to late 50 percent Cmax,IAsp, the last time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp
Minutes
t½, terminal half-life for insulin aspart
Minutes
Number of treatment emergent adverse events
Count of Events
Number of treatment emergent hypoglycaemic episodes
Count of Episodes

Full Information

First Posted
December 21, 2020
Last Updated
July 7, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04698018
Brief Title
A Research Study to Look at How Faster Aspart Works in Chinese People With Type 1 Diabetes or Type 2 Diabetes
Official Title
A Trial Investigating the Pharmacokinetic Properties of Fast-acting Insulin Aspart in Chinese Subjects With Type 1 Diabetes or Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
January 9, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

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 looks at how faster aspart reaches and stays in the blood after injection in Chinese people with type 1 diabetes or type 2 diabetes, compared to the reference product called NovoRapid®. Participants will get both faster aspart and NovoRapid®. The order in which Participants get them is decided by chance. Participants will get each study medicine once during the study meaning that they will get a total of 2 injections with study medicines. The medicine will be injected under the skin of the lower abdomen. The study will last for about 19-72 days. Participants will have 5 clinic visits with the study doctor (including the one in which participants give their consent). Participants will need to stay overnight for 2 of the 5 clinic visits. Participants will have blood samples taken during some of the clinic visits. During the visits where participants get the study medicines, samples of their blood will be taken several times for up to 12 hours after getting the study medicine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

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
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Faster aspart
Arm Type
Experimental
Arm Description
Subjects will receive 2 injections of a single dose of faster aspart at a predefined fixed dose level (0.2 U/kg body weight) for type 1 diabetes and (0.3 U/kg body weight) if subject has type 2 diabetes.
Arm Title
NovoRapid®
Arm Type
Active Comparator
Arm Description
Subjects will receive 2 injections of a single dose of NovoRapid® at a predefined fixed dose level (0.2 U/kg body weight) for type 1 diabetes and (0.3 U/kg body weight) if subject has type 2 diabetes.
Intervention Type
Drug
Intervention Name(s)
Faster Aspart
Intervention Description
Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.
Intervention Type
Drug
Intervention Name(s)
Novo Rapid
Intervention Description
Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.
Primary Outcome Measure Information:
Title
AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes
Description
pmol·h/L
Time Frame
0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Secondary Outcome Measure Information:
Title
AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve from 0 to 15 minutes
Description
pmol·h/L
Time Frame
0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Title
AUCIAsp,0-1h, area under the serum insulin aspart concentration-time curve from 0 to 1 hour
Description
pmol·h/L
Time Frame
0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Title
AUCIAsp,0-1½h, area under the serum insulin aspart concentration-time curve from 0 to 1½ hours
Description
pmol·h/L
Time Frame
0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Title
AUCIAsp,0-2h, area under the serum insulin aspart concentration-time curve from 0 to 2 hours
Description
pmol·h/L
Time Frame
0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Title
AUCIAsp,0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
Description
pmol·h/L
Time Frame
0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Title
Cmax,IAsp, maximum observed serum insulin aspart concentration
Description
pmol/L
Time Frame
0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Title
tmax,IAsp, time to maximum observed serum insulin aspart concentration
Description
Minutes
Time Frame
0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Title
Onset of appearanceIAsp, time from trial product administration until the first time serum insulin aspart concentration greater than or equal to lower limit of quantification (LLOQ)
Description
Minutes
Time Frame
0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Title
Time to 50 percent Cmax, IAsp, the first time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp
Description
Minutes
Time Frame
0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Title
Time to late 50 percent Cmax,IAsp, the last time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp
Description
Minutes
Time Frame
0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Title
t½, terminal half-life for insulin aspart
Description
Minutes
Time Frame
0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Title
Number of treatment emergent adverse events
Description
Count of Events
Time Frame
Until 7 days after IMP (investigational medicinal product) administration
Title
Number of treatment emergent hypoglycaemic episodes
Description
Count of Episodes
Time Frame
No longer than 16 hours after IMP administration until next administration of insulin (non-investigational medicinal product (NIMP) or subject's pre-trial insulin)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: For a subject with type 1 diabetes mellitus: Male or female Chinese subjects aged 18-64 years (both inclusive) at the time of signing informed consent. Type 1 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening. Treated with multiple daily insulin injections or premix insulin greater than or equal to 12 months prior to the day of screening or treated with continuous subcutaneous insulin infusion (CSII) greater than or equal to 3 months prior to the day of screening. Glycosylated haemoglobin (HbA1c) less than or equal to 9.0 percent (75 mmol/mol) by central laboratory analysis. For a subject with type 2 diabetes mellitus: Male or female Chinese subjects aged 18-75 years (both inclusive) at the time of signing informed consent. Type 2 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening. Treated with multiple daily insulin injections or premix insulin greater than or equal to 6 months prior to the day of screening or treated with continuous subcutaneous insulin infusion (CSII) greater than or equal to 3 months prior to the day of screening. Glycosylated haemoglobin less than or equal to 9.5 percent (80 mmol/mol) by central laboratory analysis. Exclusion criteria: For a subject with type 1 diabetes mellitus or type 2 diabetes mellitus: Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol. Surgery or trauma with significant blood loss (more than 400 mL) within the last 3 months prior to screening. Not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (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
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shatin, New Territories
Country
Hong Kong
Individual Site Status
Completed
Facility Name
Novo Nordisk Investigational Site
City
Shatin, New Territories
Country
Hong Kong
Individual Site Status
Recruiting

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 to Look at How Faster Aspart Works in Chinese People With Type 1 Diabetes or Type 2 Diabetes

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