Evaluation of the Bioavailability of Pramlintide

This study has been completed.

Sponsor:

Information provided by:

Amylin Pharmaceuticals, LLC.

ClinicalTrials.gov Identifier:

NCT00042471

First received: July 30, 2002

Last updated: February 11, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	July 30, 2002
Last Updated Date	February 11, 2013
Start Date ^ICMJE	June 2002
Primary Completion Date	December 2002 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00042471 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Bioavailability of Pramlintide
Official Title ^ICMJE	Not Provided
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2
Intervention ^ICMJE	Drug: Pramlintide acetate
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	December 2002
Primary Completion Date	December 2002 (final data collection date for primary outcome measure)
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 Number ^ICMJE	NCT00042471
Other Study ID Numbers ^ICMJE	137-153
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Amylin Pharmaceuticals, LLC.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Amylin Pharmaceuticals, LLC.
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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