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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00453375
Recruitment Status : Completed
First Posted : March 28, 2007
Last Update Posted : June 28, 2011
Information provided by:
Bayhill Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Hypoglycemia Drug: BHT-3021 Drug: BHT-Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Placebo Controlled, Safety and Pharmacodynamic Study of BHT-3021 With Open Label Cross-Over in Subjects With Type I Diabetes Mellitus
Study Start Date : October 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

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

Placebo Comparator: 2
Drug: BHT-Placebo
Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00453375

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

Additional Information:
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Responsible Party: Diane Amend, Clinical Trials Manager, Bayhill Therapeutics Identifier: NCT00453375     History of Changes
Other Study ID Numbers: BHT-3021-01
First Posted: March 28, 2007    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: January 2011
Keywords provided by Bayhill Therapeutics:
Type 1 Diabetes
Type 1 Diabetes Mellitus
autoimmune disease
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Butylated Hydroxytoluene
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs