Evaluation of the Effect of Pramlintide on Satiety and Food Intake

AstraZeneca51 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

Pramlintide acetateDRUG

Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.

PlaceboDRUG

placebo injection will be supplied in 5-mL multidose glass vials with a rubber stopper

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 2 Weeks

Secondary Outcomes

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.

Time frame: 2 Weeks

Data from ClinicalTrials.gov

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