Evaluation of the Effect of Pramlintide on Satiety and Food Intake

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00042601

Enrollment

Registered

2002-08-05

Start date

2002-07-31

Completion date

2003-10-31

Last updated

2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Brief summary

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.

Interventions

DRUGPramlintide acetate

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Change in satiety of participants on Pramlintide	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	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

Measure	Time frame	Description
Effect of pramlintide on postprandial metabolic and hormonal responses	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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026