Evaluation of the Bioavailability of Pramlintide

Sponsors

Lead Sponsor: AstraZeneca

Source AstraZeneca
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.

Overall Status Completed
Start Date June 2002
Completion Date December 2002
Primary Completion Date December 2002
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Effect of varying needle length on bioavailability of Pramlintide approximately 6days but not to exceed 14days
Secondary Outcome
Measure Time Frame
Effect of varying needle length on safety and tolerability of Pramlintide Approximately 6 days not to exceed 14days
Enrollment 75
Condition
Intervention

Intervention Type: Drug

Intervention Name: Pramlintide acetate

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.

Arm Group Label: Pramlintide acetate (AC137) injection

Other Name: Symlin (pramlintide acetate)

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Location
Facility:
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
Location Countries

United States

Verification Date

August 2015

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Pramlintide acetate (AC137) injection

Type: Experimental

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.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov