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

Primary Purpose

Diabetes, Hypoglycemia

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BHT-3021
BHT-Placebo
Sponsored by
Bayhill Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Diabetic, Diabetes, Type 1 Diabetes, Type 1 Diabetes Mellitus, autoimmune disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham School of Medicine
  • Valley Research
  • Barbara Davis Center for Childhood Diabetes
  • Private Practice
  • MedStar Research Institute
  • University of Miami, Miller School of Medicine, Diabetes Research Institute
  • Private Practice
  • Creighton Diabetes Center
  • Diabetes and Glandular Disease Center
  • Benaroya Research Institute at Virginia Mason
  • Peninsula Clinical Research Centre
  • Royal Melbourne Hospital
  • Eastern Clinical Research Unit
  • Fremantle Hospital
  • Middlemore Hospital
  • Christchurch Hospital
  • Waikato Regional Diabetes Service
  • The Diabetes Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

BHT-3021

BHT-Placebo

Outcomes

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.

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.

Full Information

First Posted
March 26, 2007
Last Updated
June 27, 2011
Sponsor
Bayhill Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00453375
Brief Title
Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayhill Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypoglycemia
Keywords
Diabetic, Diabetes, Type 1 Diabetes, Type 1 Diabetes Mellitus, autoimmune disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
BHT-3021
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
BHT-Placebo
Intervention Type
Drug
Intervention Name(s)
BHT-3021
Intervention Description
Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
BHT-Placebo
Intervention Description
Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Gottlieb, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joanne Quan, MD
Organizational Affiliation
Bayhill Therapeutics Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Len Harrison, MD
Organizational Affiliation
Walter and Eliza Hall Institute of Medical Research
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham School of Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Barbara Davis Center for Childhood Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Private Practice
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
MedStar Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20003
Country
United States
Facility Name
University of Miami, Miller School of Medicine, Diabetes Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Private Practice
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Creighton Diabetes Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Diabetes and Glandular Disease Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Benaroya Research Institute at Virginia Mason
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101-2795
Country
United States
Facility Name
Peninsula Clinical Research Centre
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Eastern Clinical Research Unit
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Middlemore Hospital
City
Otahuhu
State/Province
Auckland
ZIP/Postal Code
Private Bag 93311
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
Private Bag 4710
Country
New Zealand
Facility Name
Waikato Regional Diabetes Service
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
Private bag 3200
Country
New Zealand
Facility Name
The Diabetes Centre
City
Newtown
State/Province
Wellington
ZIP/Postal Code
Private Bag 7902
Country
New Zealand

12. IPD Sharing Statement

Links:
URL
http://www.bayhilltx.com
Description
Bayhill Therapeutics Inc., Click Here for More Information Regarding this Study.

Learn more about this trial

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

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