Back to resultsComparison of FiAsp and Aspart During Postprandial Exercise in Adults With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Insulin FiAsp
Insulin Aspart
60-minutes postprandial exercise
120-minutes postprandial exercise
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- HbA1c ≤ 9.5%.
- Patients using multiple daily injections with basal-bolus insulin regimen and insulin analogs (pre-meal: Aspart, Lispro, Guilisine or Fiasp; basal: Detemir, Glargine U100 & U300, Degludec U100).
- Written informed consent given.
Exclusion Criteria:
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Anemia (Hb < 100g/L).
- Ongoing pregnancy or breastfeeding.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Ongoing treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
- Participation to a clinical trial in the last 3 months prior to inclusion in this study.
Sites / Locations
- Institut de recherches cliniques de Montréal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Aspart - 60-minutes postprandial exercise
Aspart - 120-minutes postprandial exercise
FiAsp - 60-minutes postprandial exercise
FiAsp - 120-minutes postprandial exercise
Arm Description
Outcomes
Primary Outcome Measures
Decrease in plasma glucose levels during exercise
Difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of the exercise
Secondary Outcome Measures
Percentage of time of plasma glucose levels spent below 4 mmol/L
Decremental area under the curve of plasma glucose levels
Area under the curve of plasma glucose levels below 4 mmol/L
Number of patients with an exercise-induced hypoglycemia below 3.9 mmol/L
Number of patients with an exercise-induced hypoglycemia below 3.3 mmol/L
Number of patients requiring an oral treatment for hypoglycemia
Total number of hypoglycemia episodes requiring treatment
Percentage of time of plasma glucose levels spent above 10 mmol/L
Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L
Mean time (minutes) to the first hypoglycemic event
Amount of carbohydrates needed to treat a hypoglycemic event
Change in oxyhemoglobin in the vastus lateralis
Changes in deoxyhemoglobin in the vastus lateralis
Changes in total hemoglobin in the vastus lateralis
Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L
Percentage of time of plasma glucose levels spent below 4 mmol/L
Percentage of time of plasma glucose levels spent above 10 mmol/L
Area under the curve of plasma glucose levels below 4 mmol/L
Number of patients requiring an oral treatment for hypoglycemia
Total number of hypoglycemia episodes requiring treatment
Total amount of carbohydrates needed to treat hypoglycemic events
Area under the curve of plasma glucose levels
Total number of hypoglycemia episodes requiring treatment
Total amount of carbohydrates needed to treat hypoglycemic events
Full Information
NCT ID
NCT03659799
First Posted
September 4, 2018
Last Updated
August 31, 2023
Sponsor
Institut de Recherches Cliniques de Montreal
1. Study Identification
Unique Protocol Identification Number
NCT03659799
Brief Title
Comparison of FiAsp and Aspart During Postprandial Exercise in Adults With Type 1 Diabetes
Official Title
A Double-blind, Randomized, Cross-over Study to Compare the Impact of Rapid-acting Insulin Aspart and Faster Acting Aspart (FiAsp) on Glucose Excursion During Postprandial Exercise in Adults With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 12, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
March 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Cliniques de Montreal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypoglycemia is the main barrier for physical activity practice of patients with type 1 diabetes (T1D). For postprandial exercise, anticipation with meal insulin bolus reduction is the recommended method to reduce exercise-associated hypoglycemic risk. The impact of faster acting Aspart (FiAsp) pharmacokinetic on hypoglycemic risk has not yet been explored. This study will explore two different timings for exercise onset.
Objective: To compare the impact of rapid-acting insulin Aspart and faster acting Aspart (FiAsp) on glucose reduction during exercise.
Design: This study is a randomized, four-way, crossover study to compare the efficacy of 1) rapid-acting insulin Aspart, and 2) FiAsp on glucose reduction during an exercise performed 60 minutes or 120 minutes after breakfast. The insulin used and the timing of the exercise will be randomized. This project will be conducted at Institut de recherches cliniques de Montréal (IRCM, Montreal, Canada).
Hypothesis: Faster acting Aspart (FiAsp) will be non-inferior to insulin Aspart for hypoglycemic risk.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aspart - 60-minutes postprandial exercise
Arm Type
Active Comparator
Arm Title
Aspart - 120-minutes postprandial exercise
Arm Type
Active Comparator
Arm Title
FiAsp - 60-minutes postprandial exercise
Arm Type
Active Comparator
Arm Title
FiAsp - 120-minutes postprandial exercise
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Insulin FiAsp
Intervention Description
An insulin bolus of FiAsp will be given 5 minutes before breakfast
Intervention Type
Drug
Intervention Name(s)
Insulin Aspart
Intervention Description
An insulin bolus of Aspart will be given 5 minutes before breakfast
Intervention Type
Other
Intervention Name(s)
60-minutes postprandial exercise
Intervention Description
A 60-minute exercise at 60% of VO2 peak will be performed 60 minutes after breakfast
Intervention Type
Other
Intervention Name(s)
120-minutes postprandial exercise
Intervention Description
A 60-minute exercise at 60% of VO2 peak will be performed 120 minutes after breakfast
Primary Outcome Measure Information:
Title
Decrease in plasma glucose levels during exercise
Description
Difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of the exercise
Time Frame
60 minutes (exercise period)
Secondary Outcome Measure Information:
Title
Percentage of time of plasma glucose levels spent below 4 mmol/L
Time Frame
60 minutes (exercise period)
Title
Decremental area under the curve of plasma glucose levels
Time Frame
60 minutes (exercise period)
Title
Area under the curve of plasma glucose levels below 4 mmol/L
Time Frame
60 minutes (exercise period)
Title
Number of patients with an exercise-induced hypoglycemia below 3.9 mmol/L
Time Frame
60 minutes (exercise period)
Title
Number of patients with an exercise-induced hypoglycemia below 3.3 mmol/L
Time Frame
60 minutes (exercise period)
Title
Number of patients requiring an oral treatment for hypoglycemia
Time Frame
60 minutes (exercise period)
Title
Total number of hypoglycemia episodes requiring treatment
Time Frame
60 minutes (exercise period)
Title
Percentage of time of plasma glucose levels spent above 10 mmol/L
Time Frame
60 minutes (exercise period)
Title
Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L
Time Frame
60 minutes (exercise period)
Title
Mean time (minutes) to the first hypoglycemic event
Time Frame
60 minutes (exercise period)
Title
Amount of carbohydrates needed to treat a hypoglycemic event
Time Frame
60 minutes (exercise period)
Title
Change in oxyhemoglobin in the vastus lateralis
Time Frame
60 minutes (exercise period)
Title
Changes in deoxyhemoglobin in the vastus lateralis
Time Frame
60 minutes (exercise period)
Title
Changes in total hemoglobin in the vastus lateralis
Time Frame
60 minutes (exercise period)
Title
Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L
Time Frame
90 minutes after the end of exercise
Title
Percentage of time of plasma glucose levels spent below 4 mmol/L
Time Frame
90 minutes after the end of exercise
Title
Percentage of time of plasma glucose levels spent above 10 mmol/L
Time Frame
90 minutes after the end of exercise
Title
Area under the curve of plasma glucose levels below 4 mmol/L
Time Frame
90 minutes after the end of exercise
Title
Number of patients requiring an oral treatment for hypoglycemia
Time Frame
90 minutes after the end of exercise
Title
Total number of hypoglycemia episodes requiring treatment
Time Frame
90 minutes after the end of exercise
Title
Total amount of carbohydrates needed to treat hypoglycemic events
Time Frame
90 minutes after the end of exercise
Title
Area under the curve of plasma glucose levels
Time Frame
4.5 hours (entire protocol period)
Title
Total number of hypoglycemia episodes requiring treatment
Time Frame
4.5 hours (entire protocol period)
Title
Total amount of carbohydrates needed to treat hypoglycemic events
Time Frame
4.5 hours (entire protocol period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females ≥ 18 years of old.
Clinical diagnosis of type 1 diabetes for at least one year.
HbA1c ≤ 9.5%.
Patients using multiple daily injections with basal-bolus insulin regimen and insulin analogs (pre-meal: Aspart, Lispro, Guilisine or Fiasp; basal: Detemir, Glargine U100 & U300, Degludec U100).
Written informed consent given.
Exclusion Criteria:
Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
Anemia (Hb < 100g/L).
Ongoing pregnancy or breastfeeding.
Severe hypoglycemic episode within two weeks of screening.
Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
Ongoing treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
Participation to a clinical trial in the last 3 months prior to inclusion in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remi Rabasa-Lhoret
Organizational Affiliation
Institut de recherches cliniques de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de recherches cliniques de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Comparison of FiAsp and Aspart During Postprandial Exercise in Adults With Type 1 Diabetes
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