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Termination due to incomplete enrollment; planned data analysis not performed
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| Name | Class |
|---|---|
| WCCT Global | INDUSTRY |
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This will be a randomized, open-label, active-controlled, single dose crossover study with either three or four treatment periods. Investigational treatment is with Dance 501 Human Insulin Inhalation Solution (Dance 501) and the comparator is Insulin Lispro (Humalog®).
Target population will be Non-Diabetic individuals with mild to moderate asthma or chronic obstructive pulmonary disease (COPD) and non-diabetic individuals without underlying lung disease (healthy subjects).
The PK and PD profile of Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be compared to subcutaneous injection of insulin lispro.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dance 501 | Experimental | Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation |
|
| 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 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the insulin curve (AUC) | Area under the insulin curve (AUC) | 10 hours |
| Area under the glucose infusion rate curve (GIR) | Area under the glucose infusion rate curve (GIR) | 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the insulin curve following inhalation of salbutamol | Area under the insulin curve following inhalation of salbutamol in subjects with asthma | 10 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy S Bailey, MD | AMCR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT | Cypress | California | 90630 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung 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 | Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection |
|
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |