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Evaluation of the Bioavailability of Pramlintide

This study has been completed.
Sponsor:
Information provided by:
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00042471
First received: July 30, 2002
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
 Drug: Pramlintide acetate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Study Start Date: June 2002
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HbA1c value between 6-12%
  • BMI <= 27 kg/m2 or BMI >=30 to <= 45 kg/m2
  • Consistent insulin regimen for 2 months prior to screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042471

Locations
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States
United States, Louisiana
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States
United States, Texas
CEDRA Clinical Research, LLC
Austin, Texas, United States
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00042471     History of Changes
Other Study ID Numbers: 137-153
Study First Received: July 30, 2002
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune 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 May 16, 2013