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

September 22, 2015 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

296

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85204
        • Ana Ventures LLC
      • Phoenix, Arizona, United States, 85006
        • Phoenix Endocrinology Clinic, Ltd.
    • California
      • Concord, California, United States
        • East Bay Clinical Trial Center
      • Fresno, California, United States
        • Valley Research
      • San Diego, California, United States
        • UCSD Diabetes Research Center
      • San Mateo, California, United States
        • Diabetes Research Institute
      • Santa Barbara, California, United States
        • Sansum Medical Research Institute
      • Walnut Creek, California, United States
        • Diablo Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80262
        • Barbara Davis Center for Childhood Diabetes
    • District of Columbia
      • Washington, District of Columbia, United States
        • MedStar Clinical Research Center
    • Florida
      • Aventura, Florida, United States, 33180
        • Medical Research Unlimited
      • Aventura, Florida, United States
        • Medical Research Unlimited
      • Fort Myers, Florida, United States
        • Internal Medicine Associates
      • New Port Richey, Florida, United States
        • Suncoast Clinical Research
      • Tallahassee, Florida, United States
        • Children's Clinic
    • Georgia
      • Atlanta, Georgia, United States
        • Atlanta Diabetes Associates
    • Illinois
      • Chicago Heights, Illinois, United States, 60411
        • St. James Diabetes Center
      • Chicago Heights, Illinois, United States
        • St. James Diabetes Center
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University Outpatient Clinical Research
    • Maryland
      • Baltimore, Maryland, United States, 21012
        • University of Maryland Joslin Diabetes Center
    • Michigan
      • Detroit, Michigan, United States
        • Henry Ford Health System
      • Grand Rapids, Michigan, United States
        • Grand Rapids Associated Interns
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Radiant Research
    • Montana
      • Butte, Montana, United States
        • Mercury Street Medical
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • UNC Diabetes Care Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State Univ.-Division of Endocrinology, Diabetes
    • Oregon
      • Portland, Oregon, United States
        • Radiant Research
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States
        • Physicians for Clinical Research
    • Tennessee
      • Nashville, Tennessee, United States
        • Vanderbilt University Medical Center
    • Texas
      • Irving, Texas, United States
        • North Texas Clinical Research
      • Lufkin, Texas, United States, 75904
        • Private Practice
      • Lufkin, Texas, United States
        • Private Practice
    • Washington
      • Renton, Washington, United States
        • Rainier Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
- 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
29 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

July 30, 2002

First Submitted That Met QC Criteria

July 31, 2002

First Posted (Estimate)

August 1, 2002

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137-150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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