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This is a single center, randomized, blinded, placebo-controlled, two-period, cross-over study to evaluate the effect of pramlintide on satiety and food intake in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | A clear, colorless, sterile solution for SC injection manufactured by Amylin Pharmaceuticals, Inc. Placebo solution is the same, sterile preserved formulation, except the active ingredient, pramlintide, is omitted. |
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| Pramlintide | Active Comparator | Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection manufactured by Amylin Pharmaceuticals, Inc. It consists of pramlintide (AC137) 0.6 mg/mL in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramlintide acetate | Drug | Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in satiety of participants on Pramlintide | To assess the acute effect of pramlintide administered subcutaneously (SC) on satiety in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes. To be measured by Total caloric intake, macronutrient intake (carbohydrate, fat, protein, and other), duration of buffet meal, aand satiety data measured via a satiety assessment at Period 1 (Visit 2) and Period 2 (Visit 3). | 2 Weeks |
| Change in food intake of participants on Pramlintide | To assess the acute effect of pramlintide administered SC on food intake in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes. To be measured by Total caloric intake, macronutrient intake (carbohydrate, fat, protein, and other), duration of buffet meal, aand satiety data measured via a satiety assessment at Period 1 (Visit 2) and Period 2 (Visit 3). | 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of pramlintide on postprandial metabolic and hormonal responses | To assess the acute effect of pramlintide administered SC on postprandial metabolic and hormonal responses [glucose, triglycerides, total cholesterol, insulin, cholecystokinin (CCK), and glucagon-like peptide (GLP-1)] in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes. To be measured by the calculation of both absolute and incremental plasma analyte concentration profiles. |
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For Healthy Volunteers:
•BMI >=20 to <=25kg/m2 or >=30 to <=40 kg/m2
For Subjects with Type 1 or Type 2 Diabetes:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
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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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| Placebo | Drug | placebo injection will be supplied in 5-mL multidose glass vials with a rubber stopper |
|
| 2 Weeks |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |