Evaluation of the Effect of Pramlintide on Satiety and Food Intake - Tabular View

Tracking Information
First Received Date ^ICMJE	August 1, 2002
Last Updated Date	November 5, 2007
Start Date ^ICMJE	July 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00042601 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Effect of Pramlintide on Satiety and Food Intake
Official Title ^ICMJE
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Condition ^ICMJE	Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2
Intervention ^ICMJE	Drug: Pramlintide acetate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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	Male
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Australia

Administrative Information
NCT ID ^ICMJE	NCT00042601
Responsible Party
Study ID Numbers ^ICMJE	137-149
Study Sponsor ^ICMJE	Amylin Pharmaceuticals, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Amylin Pharmaceuticals, Inc.
Verification Date	November 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP