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21 Day Comparison of Continuous Insulin Infusion Using HDV Insulin to Standard Insulin in Type 1 Diabetes Mellitus

NCT03156361 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-07-31

No results posted yet for this study

Summary

Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose Safety, Tolerability and Efficacy Study

Conditions

  • Type1 Diabetes Mellitus

Interventions

DRUG

HDV insulin lispro 100 UNIT/mL

Hepatic Directed Vesicle (HDV) added to commercial insulin lispro

DRUG

Insulin Lispro 100 Units/mL

Sterile Water for Injection added to commercial insulin lispro

Sponsors & Collaborators

  • Integrium

    collaborator INDUSTRY

  • Diasome Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Douglas Muchmore, MD · Diasome Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-05-18
Primary Completion
2018-01-15
Completion
2018-03-15
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 NCT03156361 on ClinicalTrials.gov