Evaluation of the Bioavailability of Pramlintide - Tabular View

Tracking Information
First Received Date ^ICMJE	July 30, 2002
Last Updated Date	November 5, 2007
Start Date ^ICMJE	June 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00042471 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Bioavailability of Pramlintide
Official Title ^ICMJE
Brief Summary	This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Bio-availability 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	Inclusion Criteria: HbA1c value between 6-12% BMI <= 27 kg/m2 or BMI >=30 to <= 45 kg/m2 Consistent insulin regimen for 2 months prior to screening
Gender	Both
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	United States

Administrative Information
NCT ID ^ICMJE	NCT00042471
Responsible Party
Study ID Numbers ^ICMJE	137-153
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