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Clinical Trial Details

Trial ID: L2070
Source ID: NCT04100473
Associated Drug: Inhaled Human Insulin
Title: Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus
Acronym: T2DM
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Inhaled Human Insulin|DRUG: Insulin Lispro (Humalog U-100)
Outcome Measures: Primary: Primary Pharmacokinetic Endpoint - PK 1, Area under the human insulin and insulin lispro concentrations time curves, 0 - 10 hours|Primary Pharmacokinetic Endpoint - PK 2, Maximum observed concentration of human insulin and insulin lispro, 0 - 10 hours|Primary Pharmacodynamic Endpoint - PD 1, Area under the glucose infusion rate time curve, 0 - 10 hours|Primary Pharmacodynamic Endpoint - PD 2, Maximum observed glucose infusion rate, 0 - 10 hours | Secondary: Secondary Pharmacokinetic Endpoint - PK 1, Area under the insulin time curves at different intervals, 0 - 1 hour, 0 - 2 hours, 0 - 8 hours|Secondary Pharmacokinetic Endpoint - PK 2, Time to maximum insulin concentrations, 0 - 10 hours|Secondary Pharmacokinetic Endpoint - PK 3, Relative Efficiency of dose corrected ratio of AUC ins for INH and s.c. lispro, 0 - 10 hours|Secondary Pharmacokinetic Endpoint - PK 4, Onset of appearance (time from trial product administration until the serum insulin concentrations are \> LLOQ., 0 - 10 hours|Secondary Pharmacokinetic Endpoint - PK 5, Mean residence time of insulin, 0 - 10 hours|Secondary Pharmacodynamic Endpoint - PD 1, AUC for GIR at different time intervals, 0 - 1 hour, 0 - 2 hours, 0 - 8 hours|Secondary Pharmacodynamic Endpoint - PD2, Time to maximum glucose infusion rate, 0 - 10 hours|Secondary Pharmacodynamic Endpoint - PD3, Relative biopotency of dose corrected ratio of AUC GIR for INH and s.c. lispro, 0 - 10 hours
Sponsor/Collaborators: Sponsor: Dance Biopharm Inc. | Collaborators: Profil Institut für Stoffwechselforschung GmbH
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-04-23
Completion Date: 2019-08-01
Results First Posted:
Last Update Posted: 2019-09-24
Locations: Profil Mainz, Mainz, Malakoff-Passage, Germany
URL: https://clinicaltrials.gov/show/NCT04100473