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

AstraZeneca190 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

190

Conditions

Diabetes Mellitus, Type 1

Interventions

pramlintide acetateDRUG

Syringe vial and Pen-cartridge

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The subject has completed the full dosing period in Protocol 137-150.

Locations (25)

Research Site

Tempe, Arizona, United States

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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