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Afrezza Safety and Pharmacokinetics Study in Pediatric Patients

NCT02527265 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-06

Study results available
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Summary

Primary Objective:

-To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1 diabetes mellitus (T1DM).

Secondary Objectives:

* To assess the ability to titrate the prandial and supplemental doses of Afrezza at each meal.
* To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4 to 17 years with T1DM.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

BIOLOGICAL

Afrezza

Pharmaceutical form: powder Route of administration: inhalation

Sponsors & Collaborators

  • Mannkind Corporation

    lead INDUSTRY

Principal Investigators

  • Clinical Operations · Mannkind Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2020-03-17
Completion
2020-06-25
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 NCT02527265 on ClinicalTrials.gov