A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT

October 9, 2012 updated by: Diamyd Therapeutics AB

A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (USA)

The intended purpose of this study was to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.

Based on results from other clinical trials with the study drug it was judged unlikely this study would meet the intended primary or secondary efficacy endpoints. Therefore the primary focus of this study was changed to ensure that safety data was available for at least 6 months following the last dose of active study drug. Thereafter the study was terminated.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

331

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
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital Research Institute
      • Rogers, Arkansas, United States, 72758
        • Alex Endocrine Associates
    • California
      • Orange, California, United States, 92868
        • Children's Hospital Orange County
      • San Diego, California, United States, 92123
        • Rady Children's Hospital
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center for Childhood Diabetes
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christina Care Research institute
    • Florida
      • Gainsville, Florida, United States, 32610
        • University of Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic
      • Miami, Florida, United States, 33155
        • Miami Children's Hospital Research Institute
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Atlanta Diabetes Associates
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Diabetes and Osteoporosis Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinicals
    • Kansas
      • Wichita, Kansas, United States, 67211
        • Mid America Diabetes Associates
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky College of Medicine
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Research Foundation
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Children's Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Worcester, Massachusetts, United States, 01655
        • UMASS Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
      • Dearborn, Michigan, United States, 48126
        • Alzohaili Medical Consultants
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • The Children's Mercy Hospital
      • St. Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton Diabetes Center
    • Nevada
      • Reno, Nevada, United States, 89502
        • Kathryn Eckert
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Morristown, New Jersey, United States, 07962
        • Morristown Memorial Hospital
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New York, New York, United States, 10032
        • Naomi Berrie Diabetes Center of Columbia University
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Syracuse, New York, United States, 13210
        • SUNY Institute for Human Performance
    • Ohio
      • Akron, Ohio, United States, 44308
        • Children's Hospital Medical Center of Akron
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • University of Oklahoma, Schustermann Center Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh of UPMC
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Regional Medical Clinic - Endocrinology
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • LeBonheur Children's Medical Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center
      • San Antonio, Texas, United States, 78207
        • Christus Santa Rosa Children's Hospital
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98101
        • Benaroya Research Institute

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

10 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening
  • Fasting C-peptide level at time of screening above 0.1 nmol/L
  • Elevated GAD65 antibodies (GADA) at time of screening
  • Male and female patients between 10 and 20 years of age

Main Exclusion Criteria:

  • Treatment with immunosuppressants or any anti-diabetic medications other than insulin
  • A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
  • Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine
  • Participation in other clinical trials with a new chemical entity within the previous 3 months
  • Pregnancy or planned pregnancy within 1 year after the last Diamyd dose
  • Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
This arm will receive 2 subcutaneous injections with 20 µg Diamyd on days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with Diamyd 20 µg on days 90 and 270.
Drug: rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
Drug: rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
Active Comparator: B
This arm will receive 2 subcutaneous injections with 20 µg Diamyd on days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with placebo on days 90 and 270.
Drug: rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
Drug: rhGAD65
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
Placebo Comparator: C
This arm will receive 4 injections of placebo, 1 each on days 1, 30, 90 and 270.
Drug: Placebo
Placebo injected subcutaneously at days 1, 30, 90 and 270.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Meal Stimulated C-peptide (area under the curve)
Time Frame: 15 months
15 months

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 15 months
15 months
Insulin Dose
Time Frame: 15 months
15 months

Collaborators and Investigators

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

Sponsor

Diamyd Therapeutics AB

Investigators

  • Principal Investigator: Jerry Palmer, Professor, University of Washington

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

September 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 11, 2008

First Posted (Estimate)

September 12, 2008

Study Record Updates

Last Update Posted (Estimate)

October 10, 2012

Last Update Submitted That Met QC Criteria

October 9, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D/P3/07/5

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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