Clinical trial NCT03659799: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Decrease in plasma glucose levels during exercise
timeFrame: 60 minutes (exercise period)
Secondary outcomes:
measure: Percentage of time of plasma glucose levels spent below 4 mmol/L
timeFrame: 60 minutes (exercise period)
measure: Decremental area under the curve of plasma glucose levels
timeFrame: 60 minutes (exercise period)
measure: Area under the curve of plasma glucose levels below 4 mmol/L
timeFrame: 60 minutes (exercise period)
measure: Number of patients with an exercise-induced hypoglycemia below 3.9 mmol/L
timeFrame: 60 minutes (exercise period)
measure: Number of patients with an exercise-induced hypoglycemia below 3.3 mmol/L
timeFrame: 60 minutes (exercise period)
measure: Number of patients requiring an oral treatment for hypoglycemia
timeFrame: 60 minutes (exercise period)
measure: Total number of hypoglycemia episodes requiring treatment
timeFrame: 60 minutes (exercise period)
measure: Percentage of time of plasma glucose levels spent above 10 mmol/L
timeFrame: 60 minutes (exercise period)
measure: Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L
timeFrame: 60 minutes (exercise period)
measure: Mean time (minutes) to the first hypoglycemic event
timeFrame: 60 minutes (exercise period)
measure: Amount of carbohydrates needed to treat a hypoglycemic event
timeFrame: 60 minutes (exercise period)
measure: Change in oxyhemoglobin in the vastus lateralis
timeFrame: 60 minutes (exercise period)
measure: Changes in deoxyhemoglobin in the vastus lateralis
timeFrame: 60 minutes (exercise period)
measure: Changes in total hemoglobin in the vastus lateralis
timeFrame: 60 minutes (exercise period)
measure: Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L
timeFrame: 90 minutes after the end of exercise
measure: Percentage of time of plasma glucose levels spent below 4 mmol/L
timeFrame: 90 minutes after the end of exercise
measure: Percentage of time of plasma glucose levels spent above 10 mmol/L
timeFrame: 90 minutes after the end of exercise
measure: Area under the curve of plasma glucose levels below 4 mmol/L
timeFrame: 90 minutes after the end of exercise
measure: Number of patients requiring an oral treatment for hypoglycemia
timeFrame: 90 minutes after the end of exercise
measure: Total number of hypoglycemia episodes requiring treatment
timeFrame: 90 minutes after the end of exercise
measure: Total amount of carbohydrates needed to treat hypoglycemic events
timeFrame: 90 minutes after the end of exercise
measure: Area under the curve of plasma glucose levels
timeFrame: 4.5 hours (entire protocol period)
measure: Total number of hypoglycemia episodes requiring treatment
timeFrame: 4.5 hours (entire protocol period)
measure: Total amount of carbohydrates needed to treat hypoglycemic events
timeFrame: 4.5 hours (entire protocol period)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
Study officials:
affiliation: Institut de recherches cliniques de Montréal
name: Remi Rabasa-Lhoret
role: PRINCIPAL_INVESTIGATOR
References: