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Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes

NCT02713841 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-03-21

No results posted yet for this study

Summary

The purpose of this study was to compare the pharmacokinetic (PK) response after inhaled insulin administration with 3 different inhalation regimens and with subcutaneous insulin administration.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

inhaled human insulin (INH)

recombinant human insulin administered with Adagio-01 inhaler device

DRUG

sc insulin lispro (LIS)

insulin lispro administered subcutaneously

Sponsors & Collaborators

  • Dance Biopharm Inc.

    lead INDUSTRY

Principal Investigators

  • Tim Heise, MD · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-07-31
Completion
2013-07-31

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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 NCT02713841 on ClinicalTrials.gov