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| Name | Class |
|---|---|
| Profil Institut für Stoffwechselforschung GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dance 501 | Experimental | Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered using the Dance 501 Inhaler. |
|
| Insulin Lispro | Active Comparator | Insulin Lispro (Humalog®) will be administered by subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Human Insulin | Drug | Dance 501 administered using the Dance 501 Inhaler |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oliver Klein | Profil Institut fur Stoffwechselforschung GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Mainz | Mainz | Malakoff-Passage | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Randomized, Open-Label, Cross-Over design
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| Insulin Lispro (Humalog U-100) | Drug | Lispro |
|
|
| 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 |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |