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OpenTrials
Completed

NCT Number: NCT00107107

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Tempe, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Pramlintide acetate

Drug

Syringe vial and Pen-cartridge

Primary outcomes

  1. 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

  2. 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

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Apr 6, 2005
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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