Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus
|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
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.|