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Completed

NCT Number: NCT03659799

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin Fiasp

Drug

An insulin bolus of FiAsp will be given 5 minutes before breakfast

insulin aspart

Drug

An insulin bolus of Aspart will be given 5 minutes before breakfast

60-minutes postprandial exercise

Other

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

120-minutes postprandial exercise

Other

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Sep 6, 2018
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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