Status:
COMPLETED
Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Dance Biopharm Inc.
Collaborating Sponsors:
Profil Institut für Stoffwechselforschung GmbH
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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
- 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
- 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.
Key Trial Info
Start Date :
April 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04100473
Start Date
April 23 2018
End Date
August 1 2019
Last Update
September 24 2019
Active Locations (1)
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1
Profil Mainz
Mainz, Malakoff-Passage, Germany