Evaluation of the Bioavailability of Pramlintide
1 other identifier
interventional
75
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2002
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 30, 2002
CompletedFirst Posted
Study publicly available on registry
August 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2002
CompletedSeptember 23, 2015
August 1, 2015
6 months
July 30, 2002
September 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
approximately 6days but not to exceed 14days
Secondary Outcomes (1)
Effect of varying needle length on safety and tolerability of Pramlintide
Approximately 6 days not to exceed 14days
Study Arms (1)
Pramlintide acetate (AC137) injection
EXPERIMENTALPramlintide 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (4)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2002
First Posted
August 1, 2002
Study Start
June 1, 2002
Primary Completion
December 1, 2002
Study Completion
December 1, 2002
Last Updated
September 23, 2015
Record last verified: 2015-08