Back to resultsInvestigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
Faster-acting insulin aspart
insulin aspart
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
- Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
- Body mass index 18.5-28.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Smoker (defined as a subject who is smoking at least five 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
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Faster aspart
Insulin aspart
Arm Description
Outcomes
Primary Outcome Measures
Mean change in plasma glucose concentration
Secondary Outcome Measures
Rate of endogenous glucose production
Area under the serum insulin aspart concentration-time curve
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02568280
Brief Title
Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
Official Title
A Randomised Trial Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 6, 2015 (Actual)
Primary Completion Date
April 25, 2016 (Actual)
Study Completion Date
April 25, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in Europe. The aim of the trial is to investigate the postprandial glucose metabolism after treatment with faster-acting insulin aspart in subjects with type 1 diabetes.
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Faster aspart
Arm Type
Experimental
Arm Title
Insulin aspart
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Faster-acting insulin aspart
Intervention Description
Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.
Primary Outcome Measure Information:
Title
Mean change in plasma glucose concentration
Time Frame
From 0-1 hour after trial product administration
Secondary Outcome Measure Information:
Title
Rate of endogenous glucose production
Time Frame
From 0-6 hours after trial product administration
Title
Area under the serum insulin aspart concentration-time curve
Time Frame
From 0-6 hours after trial product 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
Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
Body mass index 18.5-28.0 kg/m^2 (both inclusive)
Exclusion Criteria:
Smoker (defined as a subject who is smoking at least five 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
Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Graz
ZIP/Postal Code
8010
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
29493118
Citation
Basu A, Pieber TR, Hansen AK, Sach-Friedl S, Erichsen L, Basu R, Haahr H. Greater early postprandial suppression of endogenous glucose production and higher initial glucose disappearance is achieved with fast-acting insulin aspart compared with insulin aspart. Diabetes Obes Metab. 2018 Jul;20(7):1615-1622. doi: 10.1111/dom.13270. Epub 2018 Mar 30.
Results Reference
result
PubMed Identifier
30402720
Citation
Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
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