Evaluation of the Effect of Pramlintide on Satiety and Food Intake

This study has been completed.

First Received: August 1, 2002 Last Updated: November 5, 2007 History of Changes

Sponsored by:	Amylin Pharmaceuticals, Inc.
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00042601

Purpose

This is a single center, randomized, blinded, placebo-controlled, two-period, cross-over study to evaluate the effect of pramlintide on satiety and food intake in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Pramlintide Pramlintide acetate

U.S. FDA Resources

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

Study Start Date:

July 2002

Eligibility

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

Criteria

For Healthy Volunteers:

BMI >=20 to <=25kg/m2 or >=30 to <=40 kg/m2

For Subjects with Type 1 or Type 2 Diabetes:

Treated with insulin for at least 6 months prior to screening
HbA1c value between 6.5-10% inclusive
BMI between 20-40kg/m2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042601

Locations

Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

More Information

Additional Information:

Link to study results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	137-149
Study First Received:	August 1, 2002
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00042601 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Pramlintide
Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
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