A Phase 2 interventional study of Inhaled Human Insulin and Insulin Lispro (Humalog U-100) in Type 2 Diabetes Mellitus, sponsored by Dance Biopharm Inc.. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-09-24.
Sponsored by Dance Biopharm Inc. · Phase 2, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Dance Biopharm Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered using the Dance 501 Inhaler.
Drug: Inhaled Human Insulin
Insulin Lispro (Humalog®) will be administered by subcutaneous injection.
Drug: Insulin Lispro (Humalog U-100)
Dance 501 administered using the Dance 501 Inhaler
Also known as: Dance 501
Lispro
Also known as: Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection
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 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
Secondary Pharmacokinetic Endpoint - PK 5
Mean residence time of insulin
Time frame: 0 - 10 hours
Secondary Pharmacodynamic Endpoint - PD 1
AUC for GIR at different time intervals
Time frame: 0 - 1 hour, 0 - 2 hours, 0 - 8 hours
Secondary Pharmacodynamic Endpoint - PD2
Time to maximum glucose infusion rate
Time frame: 0 - 10 hours
Secondary Pharmacodynamic Endpoint - PD3
Relative biopotency of dose corrected ratio of AUC GIR for INH and s.c. lispro
Time frame: 0 - 10 hours
Plan to share: No
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Dance Biopharm Inc.