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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: pramlintide acetate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pramlintide<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus | 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. | 6 months | 
| Understand management issues in subjects with type 1 and type 2 diabetes mellitus | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Amylin, Symlin, pramlintide acetate