Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes, Amylin, pramlintide, Symlin
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.
Interventions
Syringe vial and Pen-cartridge
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject has completed the full dosing period in Protocol 137-150.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed