Evaluation of the Effect of Pramlintide on Satiety and Food Intake

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00042601
• Other study ID #: 137-149
• Status: Completed
• Phase: Phase 2
• First received: August 1, 2002
• Last updated: October 20, 2015
• Start date: July 2002
• Est. completion date: October 2003

Study information

• Verified date: October 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Yes
Primary	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	Yes
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	Yes