Type 2 Diabetes MellitusPhase 1/2Samba-02NCT02716610
Dose-Response and Variability of Inhaled Insulin in Type 2 Diabetes
A Phase 1/2 study testing INH 69 U (low), INH 69 U (high) and INH 139 U in people with Type 2 Diabetes Mellitus, run by Dance Biopharm Inc..
Trial summary
Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501 inhaled human insulin Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- INH 69 U (low), INH 69 U (high) and INH 139 U
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jan 2014
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus treated with insulin injections at a total daily dose less than 1.2 U/kg/day.
- Body mass index 25-40 kg/m2
- Hemoglobin A1c 6.5-9.5%
- Forced vital capacity and forced expiratory volume in 1 second at least 75% of predicted normal values.
- Fasting c-peptide less than 1 nmol/L
Who cannot join
- 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 major disorder other than type 2 diabetes.
- Decompensated heart failure or myocardial infarction at any time or angina pectoris within the last 12 months.
- Proliferative retinopathy or maculopathy or severe neuropathy.
About this study
Official title: Samba-02: An Investigation of the Dose-Response and Subject Variability of Inhaled Insulin in Subjects With Type 2 Diabetes
Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501 inhaled human insulin
Read the detailed description
This study investigated the pharmacokinetic (PK) and pharmacodynamic (PD) properties of Dance-501, a novel inhaled human insulin liquid formulation (INH) and device. Twenty-four subjects with type 2 diabetes (T2DM) received 3 INH doses: low (69 units), medium (139 units) and high (208 units) and 1 equivalent medium dose (18 units) of subcutaneous insulin lispro (LIS).
The medium dose was repeated to determine within subject variability. PD was investigated during a 12 hour euglycemic clamp.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- INH 69 U (low), INH 69 U (high), INH 139 U, INH 208 U, LIS 18 U
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INH 69 U (low)Drug
Also called Dance-501
inhaled human insulin
INH 69 U (high)Drug
Also called Dance-501
inhaled human insulin
INH 139 UDrug
Also called Dance-501
inhaled human insulin
INH 208 UDrug
Also called Dance-501
inhaled human insulin
LIS 18 UDrug
Also called subcutaneous insulin lispro
subcutaneous insulin lispro
| Study group | Role | What they receive |
|---|---|---|
| INH 69 U (low) | Experimental | single 69 U dose administration of Dance inhaled human insulin using a low-concentration formulation (300 U/mL) Receives: Drug: INH 69 U (low) |
| INH 69 U (high) | Experimental | single 69 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL) Receives: Drug: INH 69 U (high) |
| INH 139 U | Experimental | single 139 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL) This arm was repeated in order to evaluate intra-subject variability. Receives: Drug: INH 139 U |
| INH 208 U | Experimental | single 208 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL) Receives: Drug: INH 208 U |
| LIS 18 U | Active comparator | single 18 U dose administration of subcutaneous insulin lispro using a 100 U/mL formulation This arm was repeated in order to evaluate intra-subject variability. Receives: Drug: LIS 18 U |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for insulin from 0-8 hours (AUCins0-8h)
Assessment of the linearity of the dose-response curves
Measured: 0 to 8 hours following each dose
Maximum concentration of insulin (CMaxIns)
Assessment of the linearity of the dose-response curves
Measured: up to 12 hours following each dose
Area under the curve for glucose infusion rate from 0-12 hours (AUGgir0-12h)
Assessment of the linearity of the dose-response curves
Measured: 0 to 8 hours following each dose
Maximum glucose infusion rate (GIRmax)
Assessment of the linearity of the dose-response curves
Measured: up to 12 hours following each dose
Secondary outcomes (1)
Bioavailability
Relative delivery efficiency (FREL) of inhaled human insulin (INH) compared to subcutaneous injected insulin lispro (LIS)
Measured: 0 to 8 hours following each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- 24 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
- NCT02716610
- Sponsor's protocol ID
- Samba-02
- Acronym
- Samba-02
- Status last verified
- Mar 2016
- First submitted
- 9 Mar 2016
- Last updated
- 23 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 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Samba-02: An Investigation of the Dose-Response and Subject Variability of Inhaled Insulin in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02716610
- Acronym / sponsor ID
- Samba-02 / Samba-02
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dance Biopharm Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 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.
Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501 inhaled human insulin
Detailed description
This study investigated the pharmacokinetic (PK) and pharmacodynamic (PD) properties of Dance-501, a novel inhaled human insulin liquid formulation (INH) and device. Twenty-four subjects with type 2 diabetes (T2DM) received 3 INH doses: low (69 units), medium (139 units) and high (208 units) and 1 equivalent medium dose (18 units) of subcutaneous insulin lispro (LIS).
The medium dose was repeated to determine within subject variability. PD was investigated during a 12 hour euglycemic clamp.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| INH 69 U (low) | Experimental | Drug: INH 69 U (low)single 69 U dose administration of Dance inhaled human insulin using a low-concentration formulation (300 U/mL) |
| INH 69 U (high) | Experimental | Drug: INH 69 U (high)single 69 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL) |
| INH 139 U | Experimental | Drug: INH 139 Usingle 139 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL) This arm was repeated in order to evaluate intra-subject variability. |
| INH 208 U | Experimental | Drug: INH 208 Usingle 208 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL) |
| LIS 18 U | Active comparator | Drug: LIS 18 Usingle 18 U dose administration of subcutaneous insulin lispro using a 100 U/mL formulation This arm was repeated in order to evaluate intra-subject variability. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus treated with insulin injections at a total daily dose less than 1.2 U/kg/day.
- Body mass index 25-40 kg/m2
- Hemoglobin A1c 6.5-9.5%
- Forced vital capacity and forced expiratory volume in 1 second at least 75% of predicted normal values.
- Fasting c-peptide less than 1 nmol/L
Key exclusion criteria (5 listed)
- 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 major disorder other than type 2 diabetes.
- Decompensated heart failure or myocardial infarction at any time or angina pectoris within the last 12 months.
- Proliferative retinopathy or maculopathy 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 |
|---|---|---|
| INH 69 U (low)Also: Dance-501inhaled human insulin | Drug | INH 69 U (low) |
| INH 69 U (high)Also: Dance-501inhaled human insulin | Drug | INH 69 U (high) |
| INH 139 UAlso: Dance-501inhaled human insulin | Drug | INH 139 U |
| INH 208 UAlso: Dance-501inhaled human insulin | Drug | INH 208 U |
| LIS 18 UAlso: subcutaneous insulin lisprosubcutaneous insulin lispro | Drug | LIS 18 U |
Primary outcome
Area under the curve for insulin from 0-8 hours (AUCins0-8h)
Time frame: 0 to 8 hours following each dose
Assessment of the linearity of the dose-response curves
Maximum concentration of insulin (CMaxIns)
Time frame: up to 12 hours following each dose
Assessment of the linearity of the dose-response curves
Area under the curve for glucose infusion rate from 0-12 hours (AUGgir0-12h)
Time frame: 0 to 8 hours following each dose
Assessment of the linearity of the dose-response curves
Maximum glucose infusion rate (GIRmax)
Time frame: up to 12 hours following each dose
Assessment of the linearity of the dose-response curves
1 secondary outcome
Bioavailability
Time frame: 0 to 8 hours following each dose
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 23 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 INH 69 U (low), INH 69 U (high) and INH 139 U in people with Type 2 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 23 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 curve for insulin from 0-8 hours (AUCins0-8h) (time frame: 0 to 8 hours following each dose). The study lists 4 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 23 Mar 2016.