This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide is 1.0 mg/mL for SC injection and 0.6 mg/mL for IV bolus injection.
Orlando Clinical Research Center
Orlando, Florida, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
DaVita Clinical Research
Minneapolis, Minnesota, United States
CEDRA Clinical Research, LLC
Austin, Texas, United States
Effect of varying needle length on bioavailability of Pramlintide
To determine the effect of various anatomical injection sites and varying needle lengths upon the absolute bioavailability of pramlintide when injected subcutaneously (SC) in non-obese and obese subjects with type 1 and type 2 diabetes mellitus using insulin.
Time frame: approximately 6days but not to exceed 14days
Effect of varying needle length on safety and tolerability of Pramlintide
To assess the safety and tolerability of pramlintide when injected SC at various anatomical sites and with various needle lengths in non-obese and obese subjects with type 1 and type 2 diabetes mellitus using insulin
Time frame: Approximately 6 days not to exceed 14days
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