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

Institut de Recherches Cliniques de Montreal

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Insulin Aspart; Other: 120-minutes postprandial exercise; Drug: Insulin FiAsp; Other: 60-minutes postprandial exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03659799

FiAsp-Exercise

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 4 patient groups

Aspart - 60-minutes postprandial exercise

Active Comparator group

Treatment:

Drug: Insulin Aspart

Other: 60-minutes postprandial exercise

Aspart - 120-minutes postprandial exercise

Active Comparator group

Treatment:

Other: 120-minutes postprandial exercise

Drug: Insulin Aspart

FiAsp - 60-minutes postprandial exercise

Active Comparator group

Treatment:

Drug: Insulin FiAsp

Other: 60-minutes postprandial exercise

FiAsp - 120-minutes postprandial exercise

Active Comparator group

Treatment:

Drug: Insulin FiAsp

Other: 120-minutes postprandial exercise