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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00044707
First received: September 3, 2002
Last updated: September 18, 2013
Last verified: September 2013
  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 Bristol-Myers Squibb:

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
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
Bristol-Myers Squibb
  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: September 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
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
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014