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Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus

NCT01194245 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2019-02-26

Study results available
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Summary

The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Insulin lispro

DRUG

recombinant human hyaluronidase PH20

DRUG

Insulin aspart

DRUG

Insulin glulisine

DRUG

Insulin glargine

Sponsors & Collaborators

  • Halozyme Therapeutics

    lead INDUSTRY

Principal Investigators

  • Douglas Muchmore, M.D. · Halozyme Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-08-31
Completion
2011-08-31

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 NCT01194245 on ClinicalTrials.gov