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

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ClinicalTrials.gov Identifier: NCT00044707
Recruitment Status : Completed
First Posted : September 5, 2002
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Non-Insulin-Dependent Drug: Pramlintide acetate Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : August 2002
Primary Completion Date : September 2002
Study Completion Date : September 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Pramlintide acetate (AC137)
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
Drug: Pramlintide acetate
Clear, colorless, sterile solution for SC injection.
Placebo Comparator: Placebo
Placebo solution is the same, sterile preserved formulation, except the active ingredient, pramlintide, is omitted


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044707


Locations
United States, Florida
ICSL-Clinical Studies
Fort Lauderdale, Florida, United States, 33301
Sponsors and Collaborators
AstraZeneca
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00044707     History of Changes
Other Study ID Numbers: 137-154
First Posted: September 5, 2002    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015

Keywords provided by AstraZeneca:
Diabetes Mellitus, Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pramlintide
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Amylin Receptor Agonists
Molecular Mechanisms of Pharmacological Action