Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes

NCT02713841 | Completed Phase 1

• 1 other identifier: Samba-01
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Area under the insulin human / insulin lispro concentration-time curve from 0 to 8 hours (AUCINS,0-8h)

  0 to 8 hours

• Bioavailability

  Relative delivery efficiency (FREL) of inhaled human insulin (INH) compared to s.c. injected insulin lispro (LIS)

  0 to 8 hours

Study Arms (5)

Inhaled insulin (LOM)

EXPERIMENTAL

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)

Inhaled insulin (MOM1)

EXPERIMENTAL

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)

Inhaled insulin (MOM2)

EXPERIMENTAL

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)

Inhaled insulin (HOM)

EXPERIMENTAL

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)

subcutaneous insulin lispro (LIS)

ACTIVE COMPARATOR

single 6 unit dose of insulin lispro administered subcutaneously

Drug: sc insulin lispro (LIS)

Interventions

inhaled human insulin (INH) DRUG

recombinant human insulin administered with Adagio-01 inhaler device

Also known as: Dance-501

Inhaled insulin (HOM); Inhaled insulin (LOM); Inhaled insulin (MOM1); Inhaled insulin (MOM2)

sc insulin lispro (LIS) DRUG

insulin lispro administered subcutaneously

subcutaneous insulin lispro (LIS)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dance Biopharm Inc.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tim Heise, MD

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 21, 2016
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 21, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share