Type 2 Diabetes MellitusPhase 2T2DMNCT04100473
Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus
A Phase 2 study testing Inhaled Human Insulin and Insulin Lispro (Humalog U-100) in people with Type 2 Diabetes Mellitus, run by Dance Biopharm Inc. at 1 site in Germany.
Trial summary
This will be a randomized, open-label, active-controlled, 6-period crossover study. Target population will be subjects with Type 2 Diabetes Mellitus (T2DM) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- 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
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 23 Apr 2018to 1 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with T2DM.
- BMI between 25.0 and 40.0 kg/m2.
- Treated with metformin and/or at least 1 daily injection of insulin for at least 6 months.
- Non-smoker for at least 5 years.
- Forced vital capacity and forced expiratory volume in one second is at least 75% normal.
Who cannot join
- Any condition affecting pulmonary drug absorption.
- History or presence of cancer except basal cell skin cancer or squamous cell skin cancer.
- Serious systemic infectious disease during four weeks prior to dosing.
- Clinically significant abnormal lab values.
- Proliferative retinopathy and/or severe neuropathy.
- Recurrent severe hypoglycemia.
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- Current treatment with oral anti-diabetic drugs except metformin, glucagon-like peptide receptor agonists.
- Current treatment with MAO inhibitors.
- Unstable Thyroid hormones for at least 3 months.
- Insufficient glycemic control with significant fluctuations of blood glucose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, 6-Period Cross-Over Study to Investigate the Dose Response of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Subjects With Type 2 Diabetes Mellitus (T2DM)
This will be a randomized, open-label, active-controlled, 6-period crossover study. Target population will be subjects with Type 2 Diabetes Mellitus (T2DM)
Read the detailed description
To assess the dose-response and dose-exposure of Dance 501 (Human Insulin Inhalation Solution) administered with the Dance 501 Inhaler.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Inhaled Human Insulin, Insulin Lispro (Humalog U-100)
- Keywords
- Inhaled Insulin
- 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.
Inhaled Human InsulinDrug
Also called Dance 501
Dance 501 administered using the Dance 501 Inhaler
Insulin Lispro (Humalog U-100)Drug
Also called Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection
Lispro
| Study group | Role | What they receive |
|---|---|---|
| Dance 501 | Experimental | Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered using the Dance 501 Inhaler. 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.
Primary Pharmacokinetic Endpoint - PK 1
Area under the human insulin and insulin lispro concentrations time curves
Measured: 0 - 10 hours
Primary Pharmacokinetic Endpoint - PK 2
Maximum observed concentration of human insulin and insulin lispro
Measured: 0 - 10 hours
Primary Pharmacodynamic Endpoint - PD 1
Area under the glucose infusion rate time curve
Measured: 0 - 10 hours
Primary Pharmacodynamic Endpoint - PD 2
Maximum observed glucose infusion rate
Measured: 0 - 10 hours
Secondary outcomes (8)
Secondary Pharmacokinetic Endpoint - PK 1
Area under the insulin time curves at different intervals
Measured: 0 - 1 hour, 0 - 2 hours, 0 - 8 hours
Secondary Pharmacokinetic Endpoint - PK 2
Time to maximum insulin concentrations
Measured: 0 - 10 hours
Secondary Pharmacokinetic Endpoint - PK 3
Relative Efficiency of dose corrected ratio of AUC ins for INH and s.c. lispro
Measured: 0 - 10 hours
Secondary Pharmacokinetic Endpoint - PK 4
Onset of appearance (time from trial product administration until the serum insulin concentrations are > LLOQ.
Measured: 0 - 10 hours
Secondary Pharmacokinetic Endpoint - PK 5
Mean residence time of insulin
Measured: 0 - 10 hours
Secondary Pharmacodynamic Endpoint - PD 1
AUC for GIR at different time intervals
Measured: 0 - 1 hour, 0 - 2 hours, 0 - 8 hours
Secondary Pharmacodynamic Endpoint - PD2
Time to maximum glucose infusion rate
Measured: 0 - 10 hours
Secondary Pharmacodynamic Endpoint - PD3
Relative biopotency of dose corrected ratio of AUC GIR for INH and s.c. lispro
Measured: 0 - 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start23 Apr 2018
- Primary completion11 Aug 2018
- Study completion1 Aug 2019
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Open-Label, Cross-Over design
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dance Biopharm Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Responsible party
- Sponsor
- Investigators
- Oliver Klein, Principal investigator, Profil Institut fur Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100473
- Sponsor's protocol ID
- Samba-04
- Acronym
- T2DM
- Status last verified
- Sep 2019
- First submitted
- 25 Feb 2019
- Last updated
- 24 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 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, 6-Period Cross-Over Study to Investigate the Dose Response of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Subjects With Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT04100473
- Acronym / sponsor ID
- T2DM / Samba-04
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Inhaled Insulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dance Biopharm Inc.Industry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 11 Aug 2018 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 24 Sep 2019 (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, 6-period crossover study. Target population will be subjects with Type 2 Diabetes Mellitus (T2DM)
Detailed description
To assess the dose-response and dose-exposure of Dance 501 (Human Insulin Inhalation Solution) administered with the Dance 501 Inhaler.
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 using the Dance 501 Inhaler. |
| Insulin Lispro | Active comparator | Drug: Insulin Lispro (Humalog U-100)Insulin Lispro (Humalog®) will be administered by subcutaneous injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects diagnosed with T2DM.
- BMI between 25.0 and 40.0 kg/m2.
- Treated with metformin and/or at least 1 daily injection of insulin for at least 6 months.
- Non-smoker for at least 5 years.
- Forced vital capacity and forced expiratory volume in one second is at least 75% normal.
Key exclusion criteria (10 listed)
- Any condition affecting pulmonary drug absorption.
- History or presence of cancer except basal cell skin cancer or squamous cell skin cancer.
- Serious systemic infectious disease during four weeks prior to dosing.
- Clinically significant abnormal lab values.
- Proliferative retinopathy and/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 InsulinAlso: Dance 501Dance 501 administered using the Dance 501 Inhaler | Drug | Dance 501 |
| Insulin Lispro (Humalog U-100)Also: Insulin Lispro (Humalog U-100) will be administered by subcutaneous injectionLispro | Drug | Insulin Lispro |
Primary outcome
Primary Pharmacokinetic Endpoint - PK 1
Time frame: 0 - 10 hours
Area under the human insulin and insulin lispro concentrations time curves
Primary Pharmacokinetic Endpoint - PK 2
Time frame: 0 - 10 hours
Maximum observed concentration of human insulin and insulin lispro
Primary Pharmacodynamic Endpoint - PD 1
Time frame: 0 - 10 hours
Area under the glucose infusion rate time curve
Primary Pharmacodynamic Endpoint - PD 2
Time frame: 0 - 10 hours
Maximum observed glucose infusion rate
8 secondary outcomes
Secondary Pharmacokinetic Endpoint - PK 1
Time frame: 0 - 1 hour, 0 - 2 hours, 0 - 8 hours
Secondary Pharmacokinetic Endpoint - PK 2
Time frame: 0 - 10 hours
Secondary Pharmacokinetic Endpoint - PK 3
Time frame: 0 - 10 hours
Secondary Pharmacokinetic Endpoint - PK 4
Time frame: 0 - 10 hours
Secondary Pharmacokinetic Endpoint - PK 5
Time frame: 0 - 10 hours
Secondary Pharmacodynamic Endpoint - PD 1
Time frame: 0 - 1 hour, 0 - 2 hours, 0 - 8 hours
Secondary Pharmacodynamic Endpoint - PD2
Time frame: 0 - 10 hours
Secondary Pharmacodynamic Endpoint - PD3
Time frame: 0 - 10 hours
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 24 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.
Oliver Klein principal investigator
Profil Institut fur Stoffwechselforschung GmbH
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 Type 2 Diabetes Mellitus, run by Dance Biopharm Inc. at 1 site in Germany.
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 10 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 24 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 Germany. 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 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?
Primary Pharmacokinetic Endpoint - PK 1 (time frame: 0 - 10 hours). 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 24 Sep 2019.