Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus

NCT04100473 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-09-24

No results posted yet for this study

Summary

This will be a randomized, open-label, active-controlled, 6-period crossover study. Target population will be subjects with Type 2 Diabetes Mellitus (T2DM)

Conditions

Interventions

DRUG

Inhaled Human Insulin

Dance 501 administered using the Dance 501 Inhaler

DRUG

Insulin Lispro (Humalog U-100)

Lispro

Sponsors & Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

    collaborator INDUSTRY
  • Dance Biopharm Inc.

    lead INDUSTRY

Principal Investigators

  • Oliver Klein · Profil Institut fur Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-04-23
Primary Completion
2018-08-11
Completion
2019-08-01
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Entities

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 NCT04100473 on ClinicalTrials.gov