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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659799
• Other study ID #: FiAsp-Exercise
• Status: Completed
• Phase: Phase 4
• Start date: April 12, 2019
• Est. completion date: March 30, 2023

Study information

• Verified date: March 2022
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Insulin FiAsp
An insulin bolus of FiAsp will be given 5 minutes before breakfast
• 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
• 120-minutes postprandial exercise
A 60-minute exercise at 60% of VO2 peak will be performed 120 minutes after breakfast

Locations

Country	Name	City	State
Canada	Institut de recherches cliniques de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

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