Back to resultsPK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD
Primary Purpose
Safety and Tolerability
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
inhaled human insulin
Insulin Lispro (Humalog U-100)
Sponsored by
About this trial
This is an interventional treatment trial for Safety and Tolerability focused on measuring inhaled insulin, asthma, COPD
Eligibility Criteria
Inclusion Criteria:
- non-diabetic subjects with asthma, or COPD. Non-smokers or smokers quit at least 6 months prior to enrollment. BMI <= 35 kg/m2. Fasting blood glucose <= 125 mg/dL.
Exclusion Criteria:
- pulmonary disorder other than asthma or COPD. Upper respiratory within previous 4 weeks. Significant exacerbation of asthma or COPD symptoms. Hospitalization for asthma or COPD within previous 3 months. Clinically significant medical condition. Current medications interfering with glucose metabolism.
Sites / Locations
- WCCT
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dance 501
Insulin Lispro
Arm Description
Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
Insulin Lispro (Humalog®) will be administered by subcutaneous injection
Outcomes
Primary Outcome Measures
Area under the insulin curve (AUC)
Area under the insulin curve (AUC)
Area under the glucose infusion rate curve (GIR)
Area under the glucose infusion rate curve (GIR)
Secondary Outcome Measures
Area under the insulin curve following inhalation of salbutamol
Area under the insulin curve following inhalation of salbutamol in subjects with asthma
Full Information
NCT ID
NCT03307512
First Posted
October 2, 2017
Last Updated
September 11, 2019
Sponsor
Dance Biopharm Inc.
Collaborators
WCCT Global
1. Study Identification
Unique Protocol Identification Number
NCT03307512
Brief Title
PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD
Official Title
Samba-AC: A Randomized, Open-Label, Cross-Over Study to Investigate the PK and PD Profiles of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Healthy Subjects and Non-Diabetic Subjects With Mild to Moderate Asthma or COPD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Termination due to incomplete enrollment; planned data analysis not performed
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dance Biopharm Inc.
Collaborators
WCCT Global
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This will be a randomized, open-label, active-controlled, single dose crossover study with either three or four treatment periods. Investigational treatment is with Dance 501 Human Insulin Inhalation Solution (Dance 501) and the comparator is Insulin Lispro (Humalog®).
Target population will be Non-Diabetic individuals with mild to moderate asthma or chronic obstructive pulmonary disease (COPD) and non-diabetic individuals without underlying lung disease (healthy subjects).
Detailed Description
The PK and PD profile of Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be compared to subcutaneous injection of insulin lispro.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety and Tolerability
Keywords
inhaled insulin, asthma, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Randomized, open-label, cross-over design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dance 501
Arm Type
Experimental
Arm Description
Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
Arm Title
Insulin Lispro
Arm Type
Active Comparator
Arm Description
Insulin Lispro (Humalog®) will be administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
inhaled human insulin
Other Intervention Name(s)
Dance 501
Intervention Description
Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro (Humalog U-100)
Other Intervention Name(s)
Lispro
Intervention Description
Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Area under the insulin curve (AUC)
Description
Area under the insulin curve (AUC)
Time Frame
10 hours
Title
Area under the glucose infusion rate curve (GIR)
Description
Area under the glucose infusion rate curve (GIR)
Time Frame
10 hours
Secondary Outcome Measure Information:
Title
Area under the insulin curve following inhalation of salbutamol
Description
Area under the insulin curve following inhalation of salbutamol in subjects with asthma
Time Frame
10 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
non-diabetic subjects with asthma, or COPD. Non-smokers or smokers quit at least 6 months prior to enrollment. BMI <= 35 kg/m2. Fasting blood glucose <= 125 mg/dL.
Exclusion Criteria:
pulmonary disorder other than asthma or COPD. Upper respiratory within previous 4 weeks. Significant exacerbation of asthma or COPD symptoms. Hospitalization for asthma or COPD within previous 3 months. Clinically significant medical condition. Current medications interfering with glucose metabolism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy S Bailey, MD
Organizational Affiliation
AMCR
Official's Role
Principal Investigator
Facility Information:
Facility Name
WCCT
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD
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