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Comparison of FiAsp and Aspart During Postprandial Exercise in Adults With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03659799
Recruitment Status : Not yet recruiting
First Posted : September 6, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Institut de Recherches Cliniques de Montreal

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Insulin FiAsp Drug: Insulin Aspart Other: 60-minutes postprandial exercise Other: 120-minutes postprandial exercise Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 28, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aspart - 60-minutes postprandial exercise Drug: Insulin Aspart
An insulin bolus of Aspart will be given 5 minutes before breakfast

Other: 60-minutes postprandial exercise
A 60-minute exercise at 60% of VO2 peak will be performed 60 minutes after breakfast

Active Comparator: Aspart - 120-minutes postprandial exercise Drug: Insulin Aspart
An insulin bolus of Aspart will be given 5 minutes before breakfast

Other: 120-minutes postprandial exercise
A 60-minute exercise at 60% of VO2 peak will be performed 120 minutes after breakfast

Active Comparator: FiAsp - 60-minutes postprandial exercise Drug: Insulin FiAsp
An insulin bolus of FiAsp will be given 5 minutes before breakfast

Other: 60-minutes postprandial exercise
A 60-minute exercise at 60% of VO2 peak will be performed 60 minutes after breakfast

Active Comparator: FiAsp - 120-minutes postprandial exercise Drug: Insulin FiAsp
An insulin bolus of FiAsp will be given 5 minutes before breakfast

Other: 120-minutes postprandial exercise
A 60-minute exercise at 60% of VO2 peak will be performed 120 minutes after breakfast




Primary Outcome Measures :
  1. Decrease in plasma glucose levels during exercise [ Time Frame: 60 minutes (exercise period) ]
    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 :
  1. Percentage of time of plasma glucose levels spent below 4 mmol/L [ Time Frame: 60 minutes (exercise period) ]
  2. Decremental area under the curve of plasma glucose levels [ Time Frame: 60 minutes (exercise period) ]
  3. Area under the curve of plasma glucose levels below 4 mmol/L [ Time Frame: 60 minutes (exercise period) ]
  4. Number of patients with an exercise-induced hypoglycemia below 3.9 mmol/L [ Time Frame: 60 minutes (exercise period) ]
  5. Number of patients with an exercise-induced hypoglycemia below 3.3 mmol/L [ Time Frame: 60 minutes (exercise period) ]
  6. Number of patients requiring an oral treatment for hypoglycemia [ Time Frame: 60 minutes (exercise period) ]
  7. Total number of hypoglycemia episodes requiring treatment [ Time Frame: 60 minutes (exercise period) ]
  8. Percentage of time of plasma glucose levels spent above 10 mmol/L [ Time Frame: 60 minutes (exercise period) ]
  9. Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L [ Time Frame: 60 minutes (exercise period) ]
  10. Mean time (minutes) to the first hypoglycemic event [ Time Frame: 60 minutes (exercise period) ]
  11. Amount of carbohydrates needed to treat a hypoglycemic event [ Time Frame: 60 minutes (exercise period) ]
  12. Change in oxyhemoglobin in the vastus lateralis [ Time Frame: 60 minutes (exercise period) ]
  13. Changes in deoxyhemoglobin in the vastus lateralis [ Time Frame: 60 minutes (exercise period) ]
  14. Changes in total hemoglobin in the vastus lateralis [ Time Frame: 60 minutes (exercise period) ]
  15. Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L [ Time Frame: 90 minutes after the end of exercise ]
  16. Percentage of time of plasma glucose levels spent below 4 mmol/L [ Time Frame: 90 minutes after the end of exercise ]
  17. Percentage of time of plasma glucose levels spent above 10 mmol/L [ Time Frame: 90 minutes after the end of exercise ]
  18. Area under the curve of plasma glucose levels below 4 mmol/L [ Time Frame: 90 minutes after the end of exercise ]
  19. Number of patients requiring an oral treatment for hypoglycemia [ Time Frame: 90 minutes after the end of exercise ]
  20. Total number of hypoglycemia episodes requiring treatment [ Time Frame: 90 minutes after the end of exercise ]
  21. Total amount of carbohydrates needed to treat hypoglycemic events [ Time Frame: 90 minutes after the end of exercise ]
  22. Area under the curve of plasma glucose levels [ Time Frame: 4.5 hours (entire protocol period) ]
  23. Total number of hypoglycemia episodes requiring treatment [ Time Frame: 4.5 hours (entire protocol period) ]
  24. Total amount of carbohydrates needed to treat hypoglycemic events [ Time Frame: 4.5 hours (entire protocol period) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females ≥ 18 years of old.
  2. Clinical diagnosis of type 1 diabetes for at least one year.
  3. HbA1c ≤ 9.5%.
  4. 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).
  5. Written informed consent given.

Exclusion Criteria:

  1. 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.
  2. Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  3. Anemia (Hb < 100g/L).
  4. Ongoing pregnancy or breastfeeding.
  5. Severe hypoglycemic episode within two weeks of screening.
  6. 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).
  7. Ongoing treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
  8. Participation to a clinical trial in the last 3 months prior to inclusion in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659799


Contacts
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Contact: Inès Boukabous 5149875597 ines.boukabous@ircm.qc.ca
Contact: Marie Raffray 5149875770 marie.raffray@ircm.qc.ca

Locations
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Canada, Quebec
Institut de recherches cliniques de Montréal Not yet recruiting
Montréal, Quebec, Canada, H2W 1R7
Contact: Inès Boukabous       ines.boukabous@ircm.qc.ca   
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Investigators
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Principal Investigator: Remi Rabasa-Lhoret Institut de recherches cliniques de Montréal

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Responsible Party: Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT03659799     History of Changes
Other Study ID Numbers: FiAsp-Exercise
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs