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PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM)

NCT02485327 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-03-15

No results posted yet for this study

Summary

Primary Objective:

To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM patients in a euglycemic clamp setting.

To characterize the within-subject variability in the metabolic activity (pharmacodynamic \[PD\]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic clamp setting.

Secondary Objectives:

To assess the PK characteristics of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting.

To assess the PD characteristics of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting.

To assess the safety and tolerability of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Technosphere Insulin SAR439065 Afrezza®

Pharmaceutical form: dry powder Route of administration: oral inhalation

Sponsors & Collaborators

  • Mannkind Corporation

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Germany

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 NCT02485327 on ClinicalTrials.gov