Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus

This study has been completed.

Sponsor:

Information provided by:

Amylin Pharmaceuticals, LLC.

ClinicalTrials.gov Identifier:

NCT00107107

First received: April 5, 2005

Last updated: August 23, 2006

Last verified: August 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

April 5, 2005

Last Updated Date

August 23, 2006

Start Date ^ICMJE

November 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To investigate the long term safety profile of pramlintide treatment in subjects with type 1 diabetes completing protocol 137-150.

Original Primary Outcome Measures ^ICMJE

- To investigate the long term safety profile of pramlintide treatment in subjects with type 1 diabetes completing protocol 137-150.

Change History

Complete list of historical versions of study NCT00107107 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To examine the effects of long term pramlintide treatment on HbA1c in subjects with type 1 diabetes completing protocol 137-150.
To examine the effects of long term pramlintide treatment on body weight in subjects with type 1 diabetes completing protocol 137-150.

Original Secondary Outcome Measures ^ICMJE

- To examine the effects of long term pramlintide treatment on HbA1c in subjects with type 1 diabetes completing protocol 137-150.
- To examine the effects of long term pramlintide treatment on body weight in subjects with type 1 diabetes completing protocol 137-150.

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus

Official Title ^ICMJE

A Multicenter, Open-Label, Extension Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus Completing Protocol 137-150

Brief Summary

This is a multicenter, open-label extension study designed to examine the long-term safety of pramlintide treatment in subjects with type 1 diabetes who have successfully completed treatment in the parent study 137-150.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 1

Intervention ^ICMJE

Drug: pramlintide acetate

Study Arm (s)

Publications *

Kovatchev BP, Crean J, McCall A. Pramlintide reduces the risks associated with glucose variability in type 1 diabetes. Diabetes Technol Ther. 2008 Oct;10(5):391-6.

* 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

190

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

The subject has completed the full dosing period in Protocol 137-150.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00107107

Other Study ID Numbers ^ICMJE

137-150E

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Amylin Pharmaceuticals, LLC.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Lisa Porter, MD

Amylin Pharmaceuticals, LLC.

Information Provided By

Amylin Pharmaceuticals, LLC.

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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