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

Bayhill Therapeutics

Status and phase

Completed

Phase 1

Conditions

Hypoglycemia

Diabetes

Treatments

Drug: BHT-3021

Drug: BHT-Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00453375

BHT-3021-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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