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

Dance Biopharm Inc.24 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

Inhaled Human InsulinDRUG

Dance 501 administered using the Dance 501 Inhaler

Insulin Lispro (Humalog U-100)DRUG

Lispro

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Profil Mainz

Mainz, Malakoff-Passage, Germany

Outcomes

Primary Outcomes

Primary Pharmacokinetic Endpoint - PK 1

Area under the human insulin and insulin lispro concentrations time curves

Time frame: 0 - 10 hours

Primary Pharmacokinetic Endpoint - PK 2

Maximum observed concentration of human insulin and insulin lispro

Time frame: 0 - 10 hours

Primary Pharmacodynamic Endpoint - PD 1

Area under the glucose infusion rate time curve

Time frame: 0 - 10 hours

Primary Pharmacodynamic Endpoint - PD 2

Maximum observed glucose infusion rate

Time frame: 0 - 10 hours

Secondary Outcomes

Secondary Pharmacokinetic Endpoint - PK 1

Area under the insulin time curves at different intervals

Time frame: 0 - 1 hour, 0 - 2 hours, 0 - 8 hours

Secondary Pharmacokinetic Endpoint - PK 2

Time to maximum insulin concentrations

Time frame: 0 - 10 hours

Secondary Pharmacokinetic Endpoint - PK 3

Relative Efficiency of dose corrected ratio of AUC ins for INH and s.c. lispro

Time frame: 0 - 10 hours

Secondary Pharmacokinetic Endpoint - PK 4

Onset of appearance (time from trial product administration until the serum insulin concentrations are \> LLOQ.

Time frame: 0 - 10 hours

Data from ClinicalTrials.gov

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