A Multicenter, Open-Label, Extension Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus Completing Protocol 137-150
Overview
- Phase
- Phase 3
- Intervention
- pramlintide acetate
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- AstraZeneca
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- To examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject has completed the full dosing period in Protocol 137-150.
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: pramlintide acetate
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- 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)