Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2779
Source ID: NCT00042601
Associated Drug: Pramlintide Acetate
Title: Evaluation of the Effect of Pramlintide on Satiety and Food Intake
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
Interventions: DRUG: Pramlintide acetate|DRUG: Placebo
Outcome Measures: Primary: 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: 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
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 51
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2002-07
Completion Date: 2003-10
Results First Posted:
Last Update Posted: 2015-10-21
Locations: Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia
URL: https://clinicaltrials.gov/show/NCT00042601