Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus

June 27, 2011 updated by: Bayhill Therapeutics

A Randomized, Blinded, Placebo Controlled, Safety and Pharmacodynamic Study of BHT-3021 With Open Label Cross-Over in Subjects With Type I Diabetes Mellitus

The purpose of this study is to determine the safety of BHT-3021 injections given weekly for 12 weeks and to evaluate the effect of BHT-3021 on antibody and immune (T cell) responses to autoantigens (e.g. insulin). Changes in pancreatic beta cell function, insulin requirements and blood glucose levels will also be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Type 1 diabetes results from an attack by the body's own immune system on the insulin producing cells in the pancreas. Around 80% of diagnosed patients have detectable antibodies to islet cell self-proteins including, insulin IA-2 and glutamic acid decarboxylase. The drug, BHT-3021 is being studied because an agent that stops autoimmune damage could offer patients benefit.

Study Description: A Randomized, Blinded, Placebo Controlled, Safety and Pharmacodynamic Study of BHT-3021 with Open Label Cross-Over in Subjects with Type I Diabetes Mellitus that will enroll up to 72 subjects in this trial. Subjects will be randomized to BHT-3021 or BHT-placebo in a 2:1 ratio.

The duration of the study is approximately 25 to 37 months depending on treatment assignment: 4 week Screening Period; 12 month Blinded Treatment and Evaluation Period; 12 month Cross-over Treatment and Evaluation Period (BHT-placebo subjects only); 12 month Long Term Follow-Up period.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

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

  • Australia
    • Queensland
      • Kippa Ring, Queensland, Australia, 4021
        • Peninsula Clinical Research Centre
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Ringwood East, Victoria, Australia, 3050
        • Eastern Clinical Research Unit
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital
  • New Zealand
    • Auckland
      • Otahuhu, Auckland, New Zealand, Private Bag 93311
        • Middlemore Hospital
    • Canterbury
      • Christchurch, Canterbury, New Zealand, Private Bag 4710
        • Christchurch Hospital
    • Waikato
      • Hamilton, Waikato, New Zealand, Private bag 3200
        • Waikato Regional Diabetes Service
    • Wellington
      • Newtown, Wellington, New Zealand, Private Bag 7902
        • The Diabetes Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham School of Medicine
    • California
      • Fresno, California, United States, 93720
        • Valley Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center for Childhood Diabetes
      • Denver, Colorado, United States, 80209
        • Private Practice
    • District of Columbia
      • Washington, District of Columbia, United States, 20003
        • Medstar Research Institute
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami, Miller School of Medicine, Diabetes Research Institute
      • Wellington, Florida, United States, 33414
        • Private Practice
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton Diabetes Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Diabetes and Glandular Disease Center
    • Washington
      • Seattle, Washington, United States, 98101-2795
        • Benaroya Research Institute at Virginia Mason

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Diagnosis of Type 1a Diabetes Mellitus based on ADA Criteria
  • ≤5 years since T1D was diagnosed
  • ≥ 18 years of age
  • ≤ 40 years of age at the time of diagnosis of Type 1a diabetes
  • Presence of antibodies to at least one of the following antigens:

insulin, GAD-65, or IA-2

  • Detectable fasting C-peptide level
  • C-peptide increase during screening mixed meal tolerance test with a minimal stimulated value of ≥ 0.2 pmol/mL
  • Presence of antibodies to at least one of the following antigens: insulin, GAD-65, or IA-2. If insulin antibody positive only, determination must be within 2 weeks of insulin initiation

Exclusion Criteria:

  • BMI > 30 kg/m2
  • Unstable blood sugar control defined as one or more episodes of severe hypoglycemia (defined as hypoglycemia that required the assistance of another person) within the last 30 days
  • Current use of inhalable insulin
  • Previous immunotherapy for T1D
  • Administration of an experimental agent for T1D at any time or use of an experimental device for T1D within 30 days prior to screening, unless approved by the medical monitor
  • History of any organ transplant, including islet cell transplant

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
BHT-3021
Drug: BHT-3021
Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
Placebo Comparator: 2
BHT-Placebo
Drug: BHT-Placebo
Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary endpoint in this study is safety.Safety parameters include: stimulated C-peptide response levels, opthalmologic examination, laboratory assessments, 24-hr urine protein, allergic reactions and adverse events including hypoglycemia.

Secondary Outcome Measures

Outcome Measure
The secondary endpoints are pharmacodynamic parameters. Parameters include plasmid levels and insulin mRNA levels in blood and urine, Stimulated C-peptide response and Immunological response.

Collaborators and Investigators

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

Sponsor

Bayhill Therapeutics

Investigators

  • Study Chair: Peter Gottlieb, MD, University of Colorado, Denver
  • Study Director: Joanne Quan, MD, Bayhill Therapeutics Inc.
  • Study Chair: Len Harrison, MD, Walter and Eliza Hall Institute of Medical Research

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.

Helpful Links

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

October 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

March 26, 2007

First Submitted That Met QC Criteria

March 26, 2007

First Posted (Estimate)

March 28, 2007

Study Record Updates

Last Update Posted (Estimate)

June 28, 2011

Last Update Submitted That Met QC Criteria

June 27, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHT-3021-01

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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