Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	Amylin Pharmaceuticals, Inc.
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00108004

Purpose

This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

Condition	Intervention	Phase
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus	Drug: pramlintide acetate	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Pramlintide Pramlintide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 3B, Multicenter, Open-Label Study Investigating the Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Insulin Therapy

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

Primary Outcome Measures:

To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus
To collect data regarding the selection of subjects for pramlintide administration by healthcare professionals and to further understand management issues in subjects with type 1 and type 2 diabetes mellitus

Estimated Enrollment:	400
Study Start Date:	April 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at Screening; -OR- The subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for a minimum of 6 months at Screening.
The subject has a HbA1c of 7.0% to 11.0% at Screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108004

Show 48 Study Locations

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Investigators

Study Director:

Lisa Porter, MD

Amylin Pharmaceuticals, Inc.

More Information

Publications indexed to this study:

Karl D, Philis-Tsimikas A, Darsow T, Lorenzi G, Kellmeyer T, Lutz K, Wang Y, Frias JP. Pramlintide as an adjunct to insulin in patients with type 2 diabetes in a clinical practice setting reduced A1C, postprandial glucose excursions, and weight. Diabetes Technol Ther. 2007 Apr;9(2):191-9.

Study ID Numbers:	137-155
Study First Received:	April 12, 2005
Last Updated:	June 5, 2006
ClinicalTrials.gov Identifier:	NCT00108004
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:

Diabetes
Amylin
Symlin
pramlintide acetate

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Pramlintide
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009