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

Sponsor:	Bayhill Therapeutics
Information provided by:	Bayhill Therapeutics
ClinicalTrials.gov Identifier:	NCT00453375

Purpose

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	Intervention	Phase
Diabetes Hypoglycemia	Drug: BHT-3021 Drug: BHT-Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1 Hypoglycemia Urine and Urination

U.S. FDA Resources

Further study details as provided by Bayhill Therapeutics:

Primary Outcome Measures:

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. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Designated as safety issue: Yes ]

Enrollment:	80
Study Start Date:	October 2006
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453375

Locations

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

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

More Information

Additional Information:

Bayhill Therapeutics Inc., Click Here for More Information Regarding this Study. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Diane Amend, Clinical Trials Manager, Bayhill Therapeutics
ClinicalTrials.gov Identifier:	NCT00453375 History of Changes
Other Study ID Numbers:	BHT-3021-01
Study First Received:	March 26, 2007
Last Updated:	June 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayhill Therapeutics:

Diabetic
Diabetes
Type 1 Diabetes
Type 1 Diabetes Mellitus
autoimmune disease

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases

Immune System Diseases
Butylated Hydroxytoluene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2012