Evaluation of the Bioavailability of Pramlintide

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: Pramlintide acetate

• Registration Number: NCT00042471
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-07-30
• Study First Submitted QC: 2002-07-31
• Study First Posted: 2002-08-01
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pramlintide acetate (AC137) injection	Pramlintide acetate	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 Measures

Name	Time	Method
Effect of varying needle length on bioavailability of Pramlintide	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.

Secondary Outcome Measures

Name	Time	Method
Effect of varying needle length on safety and tolerability of Pramlintide	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

Trial Locations

Locations (4)

New Orleans Center for Clinical Research; 🇺🇸 New Orleans, Louisiana, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

DaVita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States

CEDRA Clinical Research, LLC; 🇺🇸 Austin, Texas, United States