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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: pramlintide acetate

• Registration Number: NCT00107107
• Lead Sponsor: AstraZeneca

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

Not available

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-04-05
• Study First Submitted QC: 2005-04-05
• Study First Posted: 2005-04-06
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pramlintide Acetate	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.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Renton, Washington, United States