Type 1 Diabetes MellitusPhase 1/2Samba-01NCT02713841
Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes
A Phase 1/2 study testing inhaled human insulin (INH) and sc insulin lispro (LIS) in people with Type 1 Diabetes Mellitus, run by Dance Biopharm Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- inhaled human insulin (INH) and sc insulin lispro (LIS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jul 2013
- Phase
- Phase 1/2
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- inhaled human insulin (INH), sc insulin lispro (LIS)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled human insulin (INH)Drug
Also called Dance-501
recombinant human insulin administered with Adagio-01 inhaler device
sc insulin lispro (LIS)Drug
insulin lispro administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: inhaled human insulin (INH) |
| subcutaneous insulin lispro (LIS) | Active comparator | single 6 unit dose of insulin lispro administered subcutaneously Receives: Drug: sc insulin lispro (LIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the insulin human / insulin lispro concentration-time curve from 0 to 8 hours (AUCINS,0-8h)
Measured: 0 to 8 hours
Bioavailability
Relative delivery efficiency (FREL) of inhaled human insulin (INH) compared to s.c. injected insulin lispro (LIS)
Measured: 0 to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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 1/2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dance Biopharm Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Heise, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713841
- Sponsor's protocol ID
- Samba-01
- Acronym
- Samba-01
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2016
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Samba-01: A Phase 1/2 Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of Inhaled Insulin in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02713841
- Acronym / sponsor ID
- Samba-01 / Samba-01
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dance Biopharm Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Mar 2016 (estimated)
- 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.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Inhaled insulin (LOM) | Experimental | Drug: inhaled human insulin (INH)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) |
| Inhaled insulin (MOM1) | Experimental | Drug: inhaled human insulin (INH)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) |
| Inhaled insulin (MOM2) | Experimental | Drug: inhaled human insulin (INH)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) |
| Inhaled insulin (HOM) | Experimental | Drug: inhaled human insulin (INH)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) |
| subcutaneous insulin lispro (LIS) | Active comparator | Drug: sc insulin lispro (LIS)single 6 unit dose of insulin lispro administered subcutaneously |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 insulin (INH)Also: Dance-501recombinant human insulin administered with Adagio-01 inhaler device | Drug | Inhaled insulin (HOM), Inhaled insulin (LOM), Inhaled insulin (MOM1), Inhaled insulin (MOM2) |
| sc insulin lispro (LIS)insulin lispro administered subcutaneously | Drug | subcutaneous insulin lispro (LIS) |
Primary outcome
Area under the insulin human / insulin lispro concentration-time curve from 0 to 8 hours (AUCINS,0-8h)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- 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.
Tim Heise, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing inhaled human insulin (INH) and sc insulin lispro (LIS) in people with Type 1 Diabetes Mellitus, run by Dance Biopharm Inc..
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 human / insulin lispro concentration-time curve from 0 to 8 hours (AUCINS,0-8h) (time frame: 0 to 8 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 21 Mar 2016.