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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02713841
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Dance Biopharm Inc.

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: inhaled human insulin (INH) Drug: sc insulin lispro (LIS) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Samba-01: A Phase 1/2 Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of Inhaled Insulin in Subjects With Type 1 Diabetes
Study Start Date : May 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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 Name: 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 Name: 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 Name: 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 Name: 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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713841


Sponsors and Collaborators
Dance Biopharm Inc.
Investigators
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Principal Investigator: Tim Heise, MD Profil Institut für Stoffwechselforschung GmbH

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Responsible Party: Dance Biopharm Inc.
ClinicalTrials.gov Identifier: NCT02713841    
Other Study ID Numbers: Samba-01
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs