Evaluation of the Effect of Pramlintide on Satiety and Food Intake

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: October 2003

Interventions

  • Drug: Pramlintide acetate
    • Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
  • Drug: Placebo
    • placebo injection will be supplied in 5-mL multidose glass vials with a rubber stopper

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • 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.
  • Active Comparator: Pramlintide
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in satiety of participants on Pramlintide
    • Time Frame: 2 Weeks
    • 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).
  • Change in food intake of participants on Pramlintide
    • Time Frame: 2 Weeks
    • 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).

Secondary Measures

  • Effect of pramlintide on postprandial metabolic and hormonal responses
    • Time Frame: 2 Weeks
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor

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