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

Tracking Information

First Received Date ^ICMJE

March 26, 2007

Last Updated Date

June 10, 2008

Start Date ^ICMJE

October 2006

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary endpoint in this study is safety.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00453375 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The secondary endpoints are pharmacodynamic parameters

Original Secondary Outcome Measures ^ICMJE

Changes in immune response to insulin and changes in pancreatic function.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety Study

Condition ^ICMJE

Diabetes
Hypoglycemia

Intervention ^ICMJE

Drug: BHT-3021
Drug: BHT-Placebo

Study Arms / Comparison Groups

Experimental: BHT-3021
Placebo Comparator: BHT-Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kathryn A Woody

650-320-2838

kwoody@bayhilltx.com

Location Countries ^ICMJE

United States, Australia, New Zealand

Administrative Information

NCT ID ^ICMJE

NCT00453375

Responsible Party

Kathryn Woody, Clinical Trials Manager, Bayhill Therapeutics

Study ID Numbers ^ICMJE

BHT-3021-01

Study Sponsor ^ICMJE

Bayhill Therapeutics

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Bayhill Therapeutics

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP