Evaluation of the Bioavailability of Pramlintide

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: July 30, 2002
Last updated: June 4, 2014
Last verified: June 2014

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:

Further study details as provided by AstraZeneca:

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

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00042471

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
  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: June 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 31, 2015