Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501 inhaled human insulin
This study investigated the pharmacokinetic (PK) and pharmacodynamic (PD) properties of Dance-501, a novel inhaled human insulin liquid formulation (INH) and device. Twenty-four subjects with type 2 diabetes (T2DM) received 3 INH doses: low (69 units), medium (139 units) and high (208 units) and 1 equivalent medium dose (18 units) of subcutaneous insulin lispro (LIS). The medium dose was repeated to determine within subject variability. PD was investigated during a 12 hour euglycemic clamp.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
24
inhaled human insulin
inhaled human insulin
inhaled human insulin
Area under the curve for insulin from 0-8 hours (AUCins0-8h)
Assessment of the linearity of the dose-response curves
Time frame: 0 to 8 hours following each dose
Maximum concentration of insulin (CMaxIns)
Assessment of the linearity of the dose-response curves
Time frame: up to 12 hours following each dose
Area under the curve for glucose infusion rate from 0-12 hours (AUGgir0-12h)
Assessment of the linearity of the dose-response curves
Time frame: 0 to 8 hours following each dose
Maximum glucose infusion rate (GIRmax)
Assessment of the linearity of the dose-response curves
Time frame: up to 12 hours following each dose
Bioavailability
Relative delivery efficiency (FREL) of inhaled human insulin (INH) compared to subcutaneous injected insulin lispro (LIS)
Time frame: 0 to 8 hours following each dose
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inhaled human insulin
subcutaneous insulin lispro