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
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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