Status
Completed
Phase
Phase 2
Enrollment
75
Locations
4
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
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.
Timeline
First posted
Aug 1, 2002
Study start
Jun 2002
Primary completion
Dec 2002
Study completion
Dec 2002
Results posted
Not reported
Registry updated
Sep 23, 2015
Outcomes
Effect of varying needle length on bioavailability of Pramlintide
Time frame · approximately 6days but not to exceed 14days
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.
Effect of varying needle length on safety and tolerability of Pramlintide
Time frame · Approximately 6 days not to exceed 14days
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
Eligibility
Inclusion Criteria: * HbA1c value between 6-12% * BMI \<= 27 kg/m2 or BMI \>=30 to \<= 45 kg/m2 * Consistent insulin regimen for 2 months prior to screening
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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