Type 2 Diabetes Mellitus
Conditions
Keywords
Inhaled Insulin
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.
Interventions
Dance 501 administered using the Dance 501 Inhaler
Lispro
Sponsors
Profil Institut für Stoffwechselforschung GmbH
Dance Biopharm Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, Open-Label, Cross-Over design
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Pharmacokinetic Endpoint - PK 1 | 0 - 10 hours | Area under the human insulin and insulin lispro concentrations time curves |
| Primary Pharmacokinetic Endpoint - PK 2 | 0 - 10 hours | Maximum observed concentration of human insulin and insulin lispro |
| Primary Pharmacodynamic Endpoint - PD 1 | 0 - 10 hours | Area under the glucose infusion rate time curve |
| Primary Pharmacodynamic Endpoint - PD 2 | 0 - 10 hours | Maximum observed glucose infusion rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Pharmacokinetic Endpoint - PK 5 | 0 - 10 hours | Mean residence time of insulin |
| Secondary Pharmacodynamic Endpoint - PD 1 | 0 - 1 hour, 0 - 2 hours, 0 - 8 hours | AUC for GIR at different time intervals |
| Secondary Pharmacokinetic Endpoint - PK 1 | 0 - 1 hour, 0 - 2 hours, 0 - 8 hours | Area under the insulin time curves at different intervals |
| Secondary Pharmacodynamic Endpoint - PD3 | 0 - 10 hours | Relative biopotency of dose corrected ratio of AUC GIR for INH and s.c. lispro |
| Secondary Pharmacodynamic Endpoint - PD2 | 0 - 10 hours | Time to maximum glucose infusion rate |
| Secondary Pharmacokinetic Endpoint - PK 2 | 0 - 10 hours | Time to maximum insulin concentrations |
| Secondary Pharmacokinetic Endpoint - PK 3 | 0 - 10 hours | Relative Efficiency of dose corrected ratio of AUC ins for INH and s.c. lispro |
| Secondary Pharmacokinetic Endpoint - PK 4 | 0 - 10 hours | Onset of appearance (time from trial product administration until the serum insulin concentrations are \> LLOQ. |
Countries
Germany
Outcome results
None listed