Study of HDV Insulin Versus Insulin in Type 1 Diabetes Subjects (ISLE-1)
Status:
Completed
Trial end date:
2018-06-15
Target enrollment:
Participant gender:
Summary
This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study,
evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro
Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be
randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in
an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the
randomized treatment in combination with glargine or detemir. Goal to demonstrate that the
efficacy of HDV insulin lispro administered in combination with a basal insulin (HDV Insulin
Lispro group) is non-inferior to insulin lispro in combination with a basal insulin (Insulin
Lispro group), in effects on glycated hemoglobin (HbA1c) in patients with type 1 diabetes. If
non-inferiority is demonstrated, confirm that HDV insulin lispro in combination with a basal
insulin (HDV Insulin Lispro group) is superior to insulin lispro in combination with a basal
insulin (Insulin Lispro group), in effects on HbA1c in patients with type 1 diabetes (≥ 0.4%
decrease in HbA1c).