Clinical trial NCT04100473: Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Inhaled Insulin
Lead sponsor: Dance Biopharm Inc.
Sponsor class: INDUSTRY
Collaborators: name: Profil Institut für Stoffwechselforschung GmbH
First posted: 2019-09-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, Open-Label, Cross-Over design
Primary purpose: TREATMENT

Brief 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)

Detailed description: To assess the dose-response and dose-exposure of Dance 501 (Human Insulin Inhalation Solution) administered with the Dance 501 Inhaler.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Primary Pharmacokinetic Endpoint - PK 1
timeFrame: 0 - 10 hours
measure: Primary Pharmacokinetic Endpoint - PK 2
timeFrame: 0 - 10 hours
measure: Primary Pharmacodynamic Endpoint - PD 1
timeFrame: 0 - 10 hours
measure: Primary Pharmacodynamic Endpoint - PD 2
timeFrame: 0 - 10 hours
Secondary outcomes:
measure: Secondary Pharmacokinetic Endpoint - PK 1
timeFrame: 0 - 1 hour, 0 - 2 hours, 0 - 8 hours
measure: Secondary Pharmacokinetic Endpoint - PK 2
timeFrame: 0 - 10 hours
measure: Secondary Pharmacokinetic Endpoint - PK 3
timeFrame: 0 - 10 hours
measure: Secondary Pharmacokinetic Endpoint - PK 4
timeFrame: 0 - 10 hours
measure: Secondary Pharmacokinetic Endpoint - PK 5
timeFrame: 0 - 10 hours
measure: Secondary Pharmacodynamic Endpoint - PD 1
timeFrame: 0 - 1 hour, 0 - 2 hours, 0 - 8 hours
measure: Secondary Pharmacodynamic Endpoint - PD2
timeFrame: 0 - 10 hours
measure: Secondary Pharmacodynamic Endpoint - PD3
timeFrame: 0 - 10 hours
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Profil Mainz
state: Malakoff-Passage
Study officials:
affiliation: Profil Institut fur Stoffwechselforschung GmbH
name: Oliver Klein
role: PRINCIPAL_INVESTIGATOR
References: