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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00044707
First received: September 3, 2002
Last updated: June 4, 2014
Last verified: June 2014
  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:

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

ClinicalTrials.gov Identifier: NCT00044707     History of Changes
Other Study ID Numbers: 137-154
Study First Received: September 3, 2002
Last Updated: June 4, 2014
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
Pramlintide
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014