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
Overview
- Phase
- Phase 3
- Intervention
- pramlintide acetate
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- AstraZeneca
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at Screening; -OR- The subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for a minimum of 6 months at Screening.
- •The subject has a HbA1c of 7.0% to 11.0% at Screening.
Exclusion Criteria
- Not provided
Arms & Interventions
Pramlintide
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
Intervention: pramlintide acetate
Outcomes
Primary Outcomes
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