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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00044707
First received: September 3, 2002
Last updated: May 20, 2015
Last verified: May 2015
  Purpose

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 Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
Drug: Pramlintide acetate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To determine the effect of pramlintide on the PK of an oral medication [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]

    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:
  • safety and tolerability as measured by analysis of laboratory values and adverse events [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 24
Study Start Date: August 2002
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044707

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00044707     History of Changes
Other Study ID Numbers: 137-154
Study First Received: September 3, 2002
Last Updated: May 20, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Diabetes Mellitus, Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Islet Amyloid Polypeptide
Pramlintide
Anti-Obesity Agents
Appetite Depressants
Central Nervous System Agents
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 05, 2015