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Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide
This study has been completed.
First Received: September 3, 2002   Last Updated: December 14, 2007   History of Changes
Sponsored by: Amylin Pharmaceuticals, Inc.
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00044707
  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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Pharmacokinetics Study

Resource links provided by NLM:


Further study details as provided by Amylin Pharmaceuticals, Inc.:

Estimated Enrollment: 24
Study Start Date: August 2002
  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
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
Amylin Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Study ID Numbers: 137-154
Study First Received: September 3, 2002
Last Updated: December 14, 2007
ClinicalTrials.gov Identifier: NCT00044707     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:
Diabetes Mellitus, Type 2

Study placed in the following topic categories:
Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Pramlintide
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Pramlintide
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009