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Completed

NCT Number: NCT00044707

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

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

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Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ICSL-Clinical Studies

Fort Lauderdale, Florida, 33301, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Pramlintide acetate

Drug

Clear, colorless, sterile solution for SC injection.

Primary outcomes

  1. To determine the effect of pramlintide on the PK of an oral medication

    Time frame: 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 outcomes

  1. safety and tolerability as measured by analysis of laboratory values and adverse events

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Sep 5, 2002
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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