Evaluation of the Effect of Pramlintide on Satiety and Food Intake

Study Overview
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Brief Summary
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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.

Official Title
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A Single Center, Randomized, Double-blind, Placebo-controlled, Two-period, Crossover Study Evaluating the Acute 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 Mellitus

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Pramlintide acetate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: Treated with insulin for at least 6 months prior to screening HbA1c value between 6.5-10% inclusive BMI between 20-40kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* placebo injection will be supplied in 5-mL multidose glass vials with a rubber stopper<br>|
| Active Comparator: Pramlintide<br>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. | Drug: Pramlintide acetate<br>* Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 2 Weeks |