Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes

Samba-01: A Phase 1/2 Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of Inhaled Insulin in Subjects With Type 1 Diabetes

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02713841

Acronym

Samba-01

Enrollment

Registered

2016-03-21

Start date

2013-05-31

Completion date

2013-07-31

Last updated

2016-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Brief summary

The purpose of this study was to compare the pharmacokinetic (PK) response after inhaled insulin administration with 3 different inhalation regimens and with subcutaneous insulin administration.

Detailed description

This first-in-human trial investigated the optimal particle size for absorption of Dance-501, an aerosolized liquid human insulin for inhalation (INH). Twelve subjects with type 1 diabetes received an INH dose (50 IU) using an inhaler on 4 visits and 6 U insulin lispro (LIS) sc on a separate visit to assess relative bioavailability (FREL) of INH. The inhaler was configured to generate insulin aerosol particles sized 3.5-4.0 μm (low output mesh; LOM), 4.3-4.8 μm (medium output mesh; MOM) or 5.0-5.5 μm (high output mesh; HOM) during low inspiratory flow. To assess within subject variability, MOM was used twice. Pharmacokinetics (PK) were measured up to 8 hours after dosing.

Interventions

DRUGinhaled human insulin (INH)

recombinant human insulin administered with Adagio-01 inhaler device

DRUGsc insulin lispro (LIS)

insulin lispro administered subcutaneously

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

* Type 1 diabetes mellitus treated with multiple daily insulin injections or continuous subcutaneous insulin infusion and total daily insulin dose less than 1.2 units/kg/day. * Body mass index 18.0 - 28.0 kg/m2. * Hemoglobin A1c less than or equal to 9%. * Forced vital capacity and forced expiratory volume in one second at least 75% of predicted normal values for race, age, gender and height. * Fasting C-peptide less than 0.3 nmol/L.

Exclusion criteria

* Subjects with any condition possibly affecting drug absorption from the lung, in particular subjects with decreased lung function or subjects taking bronchodilators or subjects who smoke. * Active or chronic pulmonary disease. * Any clinically significant major disorders other than diabetes mellitus. * Decompensated heart failure at any time or angina pectoris within the last 12 months or acute myocardial infarction at any time. * Proliferative retinopathy or severe neuropathy.

Design outcomes

Primary

Measure	Time frame	Description
Area under the insulin human / insulin lispro concentration-time curve from 0 to 8 hours (AUCINS,0-8h)	0 to 8 hours	—
Bioavailability	0 to 8 hours	Relative delivery efficiency (FREL) of inhaled human insulin (INH) compared to s.c. injected insulin lispro (LIS)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026