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

Phase 4

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Insulin FiAsp; Drug: Insulin Aspart; Other: 60-minutes postprandial exercise; Other: 120-minutes postprandial exercise

• Registration Number: NCT03659799
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-06
• Study Start: 2019-04-12
• Status Verified: 2022-03
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-30
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aspart - 60-minutes postprandial exercise	60-minutes postprandial exercise	-
Aspart - 120-minutes postprandial exercise	120-minutes postprandial exercise	-
FiAsp - 60-minutes postprandial exercise	Insulin FiAsp	-
FiAsp - 60-minutes postprandial exercise	60-minutes postprandial exercise	-
FiAsp - 120-minutes postprandial exercise	Insulin FiAsp	-
FiAsp - 120-minutes postprandial exercise	120-minutes postprandial exercise	-
Aspart - 120-minutes postprandial exercise	Insulin Aspart	-
Aspart - 60-minutes postprandial exercise	Insulin Aspart	-

Primary Outcome Measures

Name	Time	Method
Decrease in plasma glucose levels during exercise	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

Name	Time	Method
Percentage of time of plasma glucose levels spent below 4 mmol/L	90 minutes after the end of exercise
Decremental area under the curve of plasma glucose levels	60 minutes (exercise period)
Area under the curve of plasma glucose levels below 4 mmol/L	90 minutes after the end of exercise
Number of patients with an exercise-induced hypoglycemia below 3.9 mmol/L	60 minutes (exercise period)
Number of patients with an exercise-induced hypoglycemia below 3.3 mmol/L	60 minutes (exercise period)
Number of patients requiring an oral treatment for hypoglycemia	90 minutes after the end of exercise
Total number of hypoglycemia episodes requiring treatment	4.5 hours (entire protocol period)
Percentage of time of plasma glucose levels spent above 10 mmol/L	90 minutes after the end of exercise
Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L	90 minutes after the end of exercise
Mean time (minutes) to the first hypoglycemic event	60 minutes (exercise period)
Amount of carbohydrates needed to treat a hypoglycemic event	60 minutes (exercise period)
Change in oxyhemoglobin in the vastus lateralis	60 minutes (exercise period)
Changes in deoxyhemoglobin in the vastus lateralis	60 minutes (exercise period)
Changes in total hemoglobin in the vastus lateralis	60 minutes (exercise period)
Total amount of carbohydrates needed to treat hypoglycemic events	4.5 hours (entire protocol period)
Area under the curve of plasma glucose levels	4.5 hours (entire protocol period)

Trial Locations

Locations (1)

Institut de recherches cliniques de Montréal; 🇨🇦 Montréal, Quebec, Canada