Evaluation of Dose-Titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control - Tabular View

Tracking Information
First Received Date ^ICMJE	July 30, 2002
Last Updated Date	November 5, 2007
Start Date ^ICMJE	April 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: November 5, 2007)	- To investigate the safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00042458 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 5, 2007)	- To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study. - To examine the pattern of daily insulin use over the course of the study.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Evaluation of Dose-Titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control
Official Title ^ICMJE	A Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety of Pramlintide Treatment Employing Pramlintide Dose-Titration Followed by Insulin Dose Optimization in Subjects With Type 1 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Intensive Insulin Therapy
Brief Summary	This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Condition ^ICMJE	Diabetes Mellitus, Type 1
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 7.5-9% Using multiple daily insulin injections
Gender	Both
Ages	18 Years and older
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	NCT00042458
Responsible Party
Study ID Numbers ^ICMJE	137-150
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