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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453375
• Other study ID #: BHT-3021-01
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2007
• Last updated: June 27, 2011
• Start date: October 2006
• Est. completion date: May 2011

Study information

• Verified date: January 2011
• Source: Bayhill Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Drug:
• BHT-3021
Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
• BHT-Placebo
Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.

Locations

Country	Name	City	State
Australia	Fremantle Hospital	Fremantle	Western Australia
Australia	Peninsula Clinical Research Centre	Kippa Ring	Queensland
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Eastern Clinical Research Unit	Ringwood East	Victoria
New Zealand	Christchurch Hospital	Christchurch	Canterbury
New Zealand	Waikato Regional Diabetes Service	Hamilton	Waikato
New Zealand	The Diabetes Centre	Newtown	Wellington
New Zealand	Middlemore Hospital	Otahuhu	Auckland
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado
United States	University of Alabama at Birmingham School of Medicine	Birmingham	Alabama
United States	Private Practice	Denver	Colorado
United States	Valley Research	Fresno	California
United States	University of Miami, Miller School of Medicine, Diabetes Research Institute	Miami	Florida
United States	Creighton Diabetes Center	Omaha	Nebraska
United States	Diabetes and Glandular Disease Center	San Antonio	Texas
United States	Benaroya Research Institute at Virginia Mason	Seattle	Washington
United States	MedStar Research Institute	Washington	District of Columbia
United States	Private Practice	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bayhill Therapeutics

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			Yes
Secondary	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.			Yes

External Links

•   Bayhill Therapeutics Inc., Click Here for More Information Regarding this Study.