CLINICAL STUDIES

Our clinical studies demonstrate the safety, efficacy and tolerability of our inhaled therapies in patients with chronic diseases in addition to validating the technology.

Phase I/II Study

SAMBA-01

Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes
Phase 1/2 pharmacokinetic study in patients with type 1 diabetes designed to determine the safety, efficiency, and dosing reliability of inhaled insulin. LEARN MORE

The study
was completed
in 2013.

Phase I/II Study

SAMBA-02

An Investigation of the Dose-Response and Subject Variability of Inhaled Insulin in Subjects with Type 2 Diabetes
Randomized, open-label, active-controlled trial investigating the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of three dose levels of inhaled insulin (9, 18 and 27 inhaled units) in patients with type 2 diabetes. LEARN MORE

The study
was completed
in 2014.

Phase I/II Study

SAMBA-03

501 Inhaled Human Insulin: Linear Dose Response in Patients with Type 1 Diabetes
Phase 1/2 study to investigate the pharmacokinetic (PK) and glucodynamic (PD) response after three doses of inhaled human insulin (INH) in patients with type 1 diabetes and compare the PK/PD responses of INH with those of three equivalent subcutaneous doses of insulin lispro. LEARN MORE

Complete
final report
in Q1 2019.
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Phase II Study

SAMBA-04

Faster Absorption and Greater Earlier Insulin Action of 501 Inhaled Human Insulin vs. s.c. Insulin Lispro in Patients with Type 2 Diabetes
Phase 1/2 study to investigate the pharmacokinetic (PK) and glucodynamic (PD) response after three doses of inhaled human insulin (INH) in patients with type 2 diabetes and compare the PK/PD responses of INH with those of three equivalent subcutaneous doses of insulin lispro.

Complete
final report
in Q4 2018.
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Phase I/II Study

SAMBA-V

Insulin Inhalation
Randomized, open-label, active-controlled study to measure the variability of inhaled human insulin dose (12 units) in type 1 diabetes patients.

Complete
final report
in Q1 2019.
VIEW POSTER

STUDY HIGHLIGHTS

Intra and
inter-subject
variability similar
to injections

Dose
linearity

PK profile:
faster onset and
longer duration
than Humalog

Minimal to
no cough

Data enables dose optimization for upcoming final PK/PD studies and Phase 3 studies