drugset / Trial / NCT02546401

Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump

NCT02546401 ↗

Phase 3 Completed 22 enrolled University Hospital, Brest
RandomizedCrossoverOpen-labelTreatment

Summary

The current study focuses on terms of use of Insulin Aspart, fast analogue of human insulin and commonly used in the treatment of type 1 diabetes, where it obtained the marketing authorization for this indication. In the patient who have an insulin pump, insulin Aspart is given daily like a pre-prandial bolus (just before the meal). However, many patients perform their bolus after the meal. However this insulin administration modality is not clearly studied in the literature.

Timeline

Start
2015-09
Primary completion
2016-03
Completion
2016-03

Outcome

Met primary endpoint

paper Mean AUC > 140 mg/dL/min was statistically higher in patients on POST PMID 29749032 ↗

paper versus PRE insulin aspart regimen (37.24 mg/dL/min 95%CI: 27.63 to 46.85) (P = 0.03). PMID 29749032 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin aspart Protein / enzyme biologic — Subcutaneous