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

September 22, 2015 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Pramlintide Acetate
Pramlintide acetate injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The concentration of pramlintide injection to be used in this study is 0.6 mg/mL.
Drug: pramlintide acetate
Syringe vial and Pen-cartridge

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To examine the effects of long term pramlintide treatment on HbA1c in subjects with type 1 diabetes completing protocol 137-150.
Time Frame: participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available
participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (ACTUAL)

June 1, 2005

Study Completion (ACTUAL)

June 1, 2005

Study Registration Dates

First Submitted

April 5, 2005

First Submitted That Met QC Criteria

April 5, 2005

First Posted (ESTIMATE)

April 6, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137-150E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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