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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT #: 2007-003430-42 |
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20 eligible subjects will be enrolled into the treatment phase of the trial.
Trial objectives are to determine the safety & pharmacological response of MKC253 Inhalation Powder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder |
|
| 2 | Experimental | 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder |
|
| 3 | Experimental | 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder |
|
| 4 | Placebo Comparator | TIP (placebo comparison) |
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| 5 | Active Comparator | 10 ug subcutaneous control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MKC253 Inhalation Powder | Drug | Inhalation Powder, prandial |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-240 min post-prandial serum glucose | 240 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Boss | Mannkind Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Groningen | Zuidlaren | 9470 AE | Netherlands |
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| Technosphere Inhalation Powder |
| Drug |
Inhalation Powder, prandial |
|
| subcutaneous injection | Drug | 10µg Exenatide, prandial |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007279 | Injections, Subcutaneous |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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