Safety and TolerabilityPhase 2NCT03307512
PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD
A Phase 2 study testing inhaled human insulin and Insulin Lispro (Humalog U-100) in people with Safety and Tolerability, run by Dance Biopharm Inc. at 1 site in United States.
Trial 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®). Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability
- What is being tested?
- inhaled human insulin and Insulin Lispro (Humalog U-100)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2018to 30 Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Safety and Tolerability
- Being tested
- inhaled human insulin, Insulin Lispro (Humalog U-100)
- Keywords
- inhaled insulin, asthma, COPD
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled human insulinDrug
Also called Dance 501
Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
Insulin Lispro (Humalog U-100)Drug
Also called Lispro
Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Dance 501 | Experimental | Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation Receives: Drug: inhaled human insulin |
| Insulin Lispro | Active comparator | Insulin Lispro (Humalog®) will be administered by subcutaneous injection Receives: Drug: Insulin Lispro (Humalog U-100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the insulin curve (AUC)
Area under the insulin curve (AUC)
Measured: 10 hours
Area under the glucose infusion rate curve (GIR)
Area under the glucose infusion rate curve (GIR)
Measured: 10 hours
Secondary outcomes (1)
Area under the insulin curve following inhalation of salbutamol
Area under the insulin curve following inhalation of salbutamol in subjects with asthma
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start6 Feb 2018
- Primary completion30 Jul 2019
- Study completion30 Aug 2019
Why it stopped: Termination due to incomplete enrollment; planned data analysis not performed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and TolerabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, open-label, cross-over design
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dance Biopharm Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WCCT Global
- Responsible party
- Sponsor
- Investigators
- Timothy S Bailey, MD, Principal investigator, AMCR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307512
- Sponsor's protocol ID
- Samba-AC
- Status last verified
- Sep 2019
- First submitted
- 2 Oct 2017
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03307512
- Acronym / sponsor ID
- Samba-AC
- Conditions
- Safety and Tolerability
- Keywords
- inhaled insulin, asthma, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination due to incomplete enrollment; planned data analysis not performed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dance Biopharm Inc.Industry (pharma, biotech, devices)
- Collaborators
- WCCT Global
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label, cross-over design
| Arm | Type | Receives |
|---|---|---|
| Dance 501 | Experimental | Drug: inhaled human insulinDance 501(Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation |
| Insulin Lispro | Active comparator | Drug: Insulin Lispro (Humalog U-100)Insulin Lispro (Humalog®) will be administered by subcutaneous injection |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhaled human insulinAlso: Dance 501Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation | Drug | Dance 501 |
| Insulin Lispro (Humalog U-100)Also: LisproInsulin Lispro (Humalog U-100) will be administered by subcutaneous injection | Drug | Insulin Lispro |
Primary outcome
Area under the insulin curve (AUC)
Time frame: 10 hours
Area under the insulin curve (AUC)
Area under the glucose infusion rate curve (GIR)
Time frame: 10 hours
Area under the glucose infusion rate curve (GIR)
1 secondary outcome
Area under the insulin curve following inhalation of salbutamol
Time frame: 10 hours
Results and safety
The study was stopped early (reason given: Termination due to incomplete enrollment; planned data analysis not performed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy S Bailey, MD principal investigator
AMCR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing inhaled human insulin and Insulin Lispro (Humalog U-100) in people with Safety and Tolerability, run by Dance Biopharm Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Termination due to incomplete enrollment; planned data analysis not performed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the insulin curve (AUC) (time frame: 10 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.