Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dance Biopharm Inc.
• Collaborator: Profil Institut für Stoffwechselforschung GmbH
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

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.