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Study of HDV Insulin Versus Insulin in Type 1 Diabetes Subjects (ISLE-1)

NCT02794155 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2018-07-31

No results posted yet for this study

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).

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

HDV Insulin Lispro

HDV Insulin Lispro: \~1% of the Insulin Lispro is bound to HDV (Hepatocyte Directed Vesicle)

DRUG

Insulin LISPRO

Insulin Lispro: no bound insulin

Sponsors & Collaborators

  • Integrium

    collaborator INDUSTRY

  • Diasome Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • David Klonoff, MD · Mills-Peninsula Health Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-04-28
Completion
2018-06-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02794155 on ClinicalTrials.gov