Evaluation of Dose-Titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control

This study has been completed.

First Received: July 30, 2002 Last Updated: November 5, 2007 History of Changes

Sponsored by:	Amylin Pharmaceuticals, Inc.
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00042458

Purpose

This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Official Title:	A Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety of Pramlintide Treatment Employing Pramlintide Dose-Titration Followed by Insulin Dose Optimization in Subjects With Type 1 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Intensive Insulin Therapy

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.:

Primary Outcome Measures:

- To investigate the safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes.

Secondary Outcome Measures:

- To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.
- To examine the pattern of daily insulin use over the course of the study.

Study Start Date:

April 2002

Eligibility

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

Criteria

Inclusion Criteria:

HbA1c value between 7.5-9%
Using multiple daily insulin injections

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042458

Show 33 Study Locations

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:	137-150
Study First Received:	July 30, 2002
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00042458 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
Endocrine System Diseases

Pramlintide
Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Physiological Effects of Drugs

Diabetes Mellitus
Endocrine System Diseases
Pramlintide
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009