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):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00042458
First received: July 30, 2002
Last updated: September 22, 2015
Last verified: August 2015
  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
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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:


Further study details as provided by AstraZeneca:

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. [ Time Frame: 29 Weeks ]

Secondary Outcome Measures:
  • - To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study. [ Time Frame: 29 Weeks ]
  • - To examine the pattern of daily insulin use over the course of the study. [ Time Frame: 29 Weeks ]

Enrollment: 296
Study Start Date: April 2002
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.Ingredients: D-Mannitol 43.0 mg/mL Metacresol 2.25 mg/mL Glacial acetic acid 1.53 mg/mL Sodium acetate trihydrate 0.61 mg/mL pH 4.0 Water for injection qs to 5.0 mL
Drug: Placebo
The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.
Active Comparator: Pramlintide Acetate (AC137)
Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide injection is 0.6 mg/mL
Drug: Pramlintide acetate
Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 33 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00042458     History of Changes
Other Study ID Numbers: 137-150 
Study First Received: July 30, 2002
Last Updated: September 22, 2015
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
Appetite Depressants
Anti-Obesity Agents
Amylin Receptor Agonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 29, 2016