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This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pramlintide acetate (AC137) injection | Experimental | Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide is 1.0 mg/mL for SC injection and 0.6 mg/mL for IV bolus injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramlintide acetate | Drug | Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide is 1.0 mg/mL for SC injection and 0.6 mg/mL for IV bolus injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of varying needle length on bioavailability of Pramlintide | To determine the effect of various anatomical injection sites and varying needle lengths upon the absolute bioavailability of pramlintide when injected subcutaneously (SC) in non-obese and obese subjects with type 1 and type 2 diabetes mellitus using insulin. | approximately 6days but not to exceed 14days |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of varying needle length on safety and tolerability of Pramlintide | To assess the safety and tolerability of pramlintide when injected SC at various anatomical sites and with various needle lengths in non-obese and obese subjects with type 1 and type 2 diabetes mellitus using insulin | Approximately 6 days not to exceed 14days |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | United States | |||
| New Orleans Center for Clinical Research |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| 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 |
|---|---|
| C105254 | pramlintide |
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|
|
| New Orleans |
| Louisiana |
| United States |
| DaVita Clinical Research | Minneapolis | Minnesota | United States |
| CEDRA Clinical Research, LLC | Austin | Texas | United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |