Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT00108004|
Recruitment Status : Completed
First Posted : April 13, 2005
Last Update Posted : May 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus||Drug: pramlintide acetate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3B, Multicenter, Open-Label Study Investigating the Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Insulin Therapy|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2005|
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
Drug: pramlintide acetate
Pramlintide (0.6 mg/mL) in 5.0-mL multiple-draw glass vials for SC injection for 12weekes and after Pramlintide (1.0 mg/mL) 1.5 mL pen-cartridge. Subjects who do not switch to the pen-cartridge device at Week 12 will continue to administer pramlintide using a syringe and vial.
- To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus [ Time Frame: 6 months ]To investigate the clinical utility (change in HbA1c, seven-point glucose profile, body weight, and insulin use) and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy.
- Understand management issues in subjects with type 1 and type 2 diabetes mellitus [ Time Frame: 6 months ]To collect data regarding the selection of subjects for pramlintide administration by healthcare professionals and to further understand management issues in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108004
Show 48 Study Locations
|Study Director:||Lisa Porter, MD||Amylin Pharmaceuticals, LLC.|