Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide

Phase 2

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent
• Interventions: Drug: Pramlintide acetate

• Registration Number: NCT00044707
• Lead Sponsor: AstraZeneca

Brief Summary

This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2002-09
• Study Completion: 2002-09
• Study First Submitted: 2002-09-03
• Study First Submitted QC: 2002-09-04
• Study First Posted: 2002-09-05
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Type 2 diabetes mellitus treated with diet and/or oral agents
• HbA1c 6.5-11.0

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pramlintide acetate (AC137)	Pramlintide acetate	Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide injection is 0.6 mg/mL

Primary Outcome Measures

Name	Time	Method
To determine the effect of pramlintide on the PK of an oral medication	7 Days	To determine the effect of pramlintide on the pharmacokinetics of an orally administered concomitant medication (acetaminophen) when administered at various times in relation to subcutaneous (SC) pramlintide dosing. The noncompartmental plasma acetaminophen pharmacokinetic (PK) parameters used in the analyses are defined as follows: AUC(0-12hr): Area under the plasma acetaminophen concentration-time curve. Cmax : The peak acetaminophen concentrationd. Tmax : Duration from the time of acetaminophen dosing to the time of the first maximum observed concentration, Cmax.; t½: Terminal half-life; The primary study endpoints include: * pharmacokinetic parameters AUC(0-12 hr) and Cmax of plasma acetaminophen concentrations Secondary Study Endpoints; * pharmacokinetic parameters Tmax and t1/2 of plasma acetaminophen concentrations

Secondary Outcome Measures

Name	Time	Method
safety and tolerability as measured by analysis of laboratory values and adverse events	7 Days	To assess safety and tolerability of pramlintide SC injection, including adverse events, as a function of the timing of an orally administered concomitant medication (acetaminophen).

Trial Locations

Locations (1)

ICSL-Clinical Studies; 🇺🇸 Fort Lauderdale, Florida, United States