Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus (T2DM)

Dance Biopharm

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Inhaled Human Insulin

Drug: Insulin Lispro (Humalog U-100)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04100473

Samba-04

Details and patient eligibility

About

This will be a randomized, open-label, active-controlled, 6-period crossover study. Target population will be subjects with Type 2 Diabetes Mellitus (T2DM)

Full description

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

Enrollment

24 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.