Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes (Samba-01)

March 15, 2016 updated by: Dance Biopharm Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhaled insulin (LOM)
single 50 unit dose of Dance inhaled insulin administered using the Adagio-01 inhaler device with a low output mesh (aerosol particles sized 3.5-4.0 μm)
Drug: inhaled human insulin (INH)
recombinant human insulin administered with Adagio-01 inhaler device
Other Names:
  • Dance-501
Experimental: Inhaled insulin (MOM1)
single 50 unit dose of Dance inhaled insulin administered using the Adagio-01 inhaler device with a medium output mesh (aerosol particles sized 4.3-4.8 μm)
Drug: inhaled human insulin (INH)
recombinant human insulin administered with Adagio-01 inhaler device
Other Names:
  • Dance-501
Experimental: Inhaled insulin (MOM2)
repeat of single 50 unit dose of Dance inhaled insulin administered using the Adagio-01 inhaler device with a medium output mesh (aerosol particles sized 4.3-4.8 μm)
Drug: inhaled human insulin (INH)
recombinant human insulin administered with Adagio-01 inhaler device
Other Names:
  • Dance-501
Experimental: Inhaled insulin (HOM)
single 50 unit dose of Dance inhaled insulin administered using the Adagio-01 inhaler device with a high output mesh (aerosol particles sized 5.0-5.5 μm)
Drug: inhaled human insulin (INH)
recombinant human insulin administered with Adagio-01 inhaler device
Other Names:
  • Dance-501
Active Comparator: subcutaneous insulin lispro (LIS)
single 6 unit dose of insulin lispro administered subcutaneously
Drug: sc insulin lispro (LIS)
insulin lispro administered subcutaneously

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dance Biopharm Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 21, 2016

Study Record Updates

Last Update Posted (Estimate)

March 21, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Samba-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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