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

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 I

MedlinePlus related topics:

Diabetes Diabetes Type 1 Hypoglycemia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety Study

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

Further study details as provided by Bayhill Therapeutics:

Primary Outcome Measures:

The primary endpoint in this study is safety.

Secondary Outcome Measures:

The secondary endpoints are pharmacodynamic parameters

Estimated Enrollment:	72
Study Start Date:	October 2006
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental BHT-3021	Drug: BHT-3021 Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
2: Placebo Comparator 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 ≥ 0.066 pmol/mL

Exclusion Criteria:

Agree to intensive management of diabetes with a HgbA1c goal of < 7.0%
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

Contacts


Contact: Kathryn A Woody	650-320-2838	kwoody@bayhilltx.com

Locations


United States, Alabama
	University of Alabama at Birmingham School of Medicine	Recruiting
	Birmingham, Alabama, United States, 35294
	Contact: Marianne Vetrano 205-934-4112 mvetrano@uab.edu
	Principal Investigator: Fernando Ovalle, MD

United States, California
	Valley Research	Recruiting
	Fresno, California, United States, 93720
	Contact: Mike Guerrero, RN 559-261-0992 ext 19
	Principal Investigator: Paul Norwood, MD

United States, Colorado
	Barbara Davis Center for Childhood Diabetes	Recruiting
	Aurora, Colorado, United States, 80045
	Contact: Amy Wallace, MA 303-724-6768 amy.wallace@UCHSC.edu
	Principal Investigator: Peter Gottlieb, MD
	Private Practice	Recruiting
	Denver, Colorado, United States, 80209
	Contact: Judi Recht, RN 303-388-6410 ext 213 jrecht47@comcast.net
	Principal Investigator: Leonard Zemel, MD

United States, District of Columbia
	MedStar Research Institute	Recruiting
	Washington, District of Columbia, United States, 20003
	Contact: Laurie Want, RN,MS 202-787-5376 Laurie.Want@Medstar.net
	Principal Investigator: Robert Ratner, MD

United States, Florida
	University of Miami, Miller School of Medicine, Diabetes Research Institute	Recruiting
	Miami, Florida, United States, 33136
	Contact: Robert Agramonte, RN, BSN 305-243-6573 ragramon@u.med.miami.edu
	Principal Investigator: Jay Skyler, MD
	Private Practice	Recruiting
	Wellington, Florida, United States, 33414
	Contact: Debbie Hays, RN 561-641-7736 superfp@aol.com
	Principal Investigator: Richard Hays, BA, MD

United States, Nebraska
	Creighton Diabetes Center	Recruiting
	Omaha, Nebraska, United States, 68131
	Contact: Benjamin Bumgarner 402-280-4324 bjb@creighton.edu
	Principal Investigator: Marc Rendell, MD

United States, Texas
	Diabetes and Glandular Disease Center	Recruiting
	San Antonio, Texas, United States, 78229
	Contact: Ben Blaylock, RN 210-615-5565 ext 1607 bblaylock@dgdresearch.com
	Principal Investigator: Mark Kipnes, MD

United States, Washington
	Benaroya Research Institute at Virginia Mason	Recruiting
	Seattle, Washington, United States, 98101-2795
	Contact: Heather Vendettuoli 206-233-6378 hventdettuoli@benaroyaresearch.org
	Principal Investigator: Carla Greenbaum, MD

Australia, Queensland
	Peninsula Clinical Research Centre	Recruiting
	Kippa Ring, Queensland, Australia, 4021
	Contact: Gay Goodman +61 7 3889 5019 jstein@acro.net.au
	Principal Investigator: Vernon Heazlewood, MD

Australia, Victoria
	Royal Melbourne Hospital	Recruiting
	Parkville, Victoria, Australia, 3050
	Contact: Lee-anne Lynch +61 3 9342 7278 Lee-Anne.Lynch@mh.org.au
	Principal Investigator: Peter Colman, MD
	Eastern Clinical Research Unit	Recruiting
	Ringwood East, Victoria, Australia, 3050
	Contact: Amy Clark +61 3 9871 3312 Amy.Clark@Easternhealth.org.au
	Principal Investigator: Murray Gerstman, MD

Australia, Western Australia
	Fremantle Hospital	Recruiting
	Fremantle, Western Australia, Australia, 6160
	Contact: Michelle England +61 8 9431 3230 mengland@cyllene.uwa.edu.au
	Principal Investigator: Tim Davis, MD

New Zealand, Auckland
	Middlemore Hospital	Recruiting
	Otahuhu, Auckland, New Zealand, Private Bag 93311
	Contact: Ruth Withers +64 9 276 0044 ext 2967 ruth.withers@middlemore.co.nz
	Principal Investigator: John Baker, MD

New Zealand, Canterbury
	Christchurch Hospital	Recruiting
	Christchurch, Canterbury, New Zealand, Private Bag 4710
	Contact: Jinny Willis, MD +64 3 364 0448 Jinny.Willis@cdhb.govt.nz
	Principal Investigator: Russell Scott, MD

New Zealand, Waikato
	Waikato Regional Diabetes Service	Recruiting
	Hamilton, Waikato, New Zealand, Private bag 3200
	Contact: Annie Johnstone + 64 7 839 8701 ext 6679 johnstoa@waikatodhb.govt.nz
	Principal Investigator: Peter Dunn, MD

New Zealand, Wellington
	The Diabetes Centre	Recruiting
	Newtown, Wellington, New Zealand, Private Bag 7902
	Contact: Linda Kent + 64 4 918 6631 linda.kent@ccdhb.org.nz
	Principal Investigator: Jeremy Krebs, MD

Sponsors and Collaborators

Bayhill Therapeutics

Investigators


Study Chair:	Peter Gottlieb, MD	Barbara Davis Center for Childhood Diabetes

Study Director:	Frank H Valone, MD	Bayhill Therapeutics Inc.

Study Chair:	Len Harrison, MD	Walter and Eliza Hall Institute of Medical Research

More Information

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

Responsible Party:	Bayhill Therapeutics ( Kathryn Woody, Clinical Trials Manager )
Study ID Numbers:	BHT-3021-01
First Received:	March 26, 2007
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00453375
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayhill Therapeutics:

Diabetic

Diabetes

Type 1 Diabetes

Type 1 Diabetes Mellitus

autoimmune disease

Study placed in the following topic categories:

Metabolic Diseases

Autoimmune Diseases

Diabetes Mellitus, Type 1

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Hypoglycemia

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on October 07, 2008

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