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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107107
• Other study ID #: 137-150E
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2005
• Last updated: September 22, 2015
• Start date: November 2002
• Est. completion date: June 2005

Study information

• Verified date: August 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• pramlintide acetate
Syringe vial and Pen-cartridge

Locations

Country	Name	City	State
United States	Research Site	Atlanta	Georgia
United States	Research Site	Aventura	Florida
United States	Research Site	Butte	Montana
United States	Research Site	Camp Hill	Pennsylvania
United States	Research Site	Columbus	Ohio
United States	Research Site	Concord	California
United States	Research Site	Detroit	Michigan
United States	Research Site	Durham	North Carolina
United States	Research Site	Fort Myers	Florida
United States	Research Site	Fresno	California
United States	Research Site	Grand Rapids	Michigan
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Irving	Texas
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Port Richey	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	Renton	Washington
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	San Mateo	California
United States	Research Site	Santa Barbara	California
United States	Research Site	St. Peters	Missouri
United States	Research Site	Tallahassee	Florida
United States	Research Site	Tempe	Arizona
United States	Research Site	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the long term safety profile of pramlintide treatment in subjects with type 1 diabetes completing protocol 137-150.		participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available	Yes
Primary	To examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight		participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available
Secondary	To examine the effects of long term pramlintide treatment on HbA1c in subjects with type 1 diabetes completing protocol 137-150.		participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available