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

This study has been completed.

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

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines 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

No publications provided

ClinicalTrials.gov Identifier:	NCT00042458 History of Changes
Other Study ID Numbers:	137-150
Study First Received:	July 30, 2002
Last Updated:	November 5, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
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 February 12, 2012