Back to resultsEvaluation of the Bioavailability of Pramlintide
Primary Purpose
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pramlintide acetate
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
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
Sites / Locations
- Orlando Clinical Research Center
- New Orleans Center for Clinical Research
- DaVita Clinical Research
- CEDRA Clinical Research, LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pramlintide acetate (AC137) injection
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00042471
Brief Title
Evaluation of the Bioavailability of Pramlintide
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pramlintide acetate (AC137) injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pramlintide acetate
Other Intervention Name(s)
Symlin (pramlintide acetate)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of varying needle length on bioavailability of Pramlintide
Description
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
Secondary Outcome Measure Information:
Title
Effect of varying needle length on safety and tolerability of Pramlintide
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
CEDRA Clinical Research, LLC
City
Austin
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Bioavailability of Pramlintide
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