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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00042458
First received: July 30, 2002
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  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 3

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:

U.S. FDA Resources

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

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
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
  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, LLC.
  More Information

No publications provided

Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT00042458     History of Changes
Other Study ID Numbers: 137-150
Study First Received: July 30, 2002
Last Updated: February 7, 2013
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 May 22, 2013