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Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro to Further Improve Glycemic Control

NCT03096392 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-07-31

No results posted yet for this study

Summary

Multi-Center, double blind, active comparator controlled multiple dose safety, tolerability and efficacy study

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

HDV insulin lispro 100 UNT/ML

HDV is the active excipient, added to insulin lispro. HDV binds to a portion of the insulin lispro.

DRUG

Insulin Lispro 100 UNT/ML

Sterile Water for Injection is added to the insulin lispro, to dilute the insulin lispro equal to the HDV insulin lispro

Sponsors & Collaborators

  • Integrium

    collaborator INDUSTRY

  • Diasome Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Douglas B Muchmore, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2017-11-15
Completion
2018-03-18
FDA Drug
Yes

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 NCT03096392 on ClinicalTrials.gov