DiabetesPhase 1NCT00453375
Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus
A Phase 1 study testing BHT-3021 in people with Diabetes and Hypoglycemia, run by Bayhill Therapeutics at 18 sites in 3 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Hypoglycemia
- What is being tested?
- BHT-3021
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Oct 2006to May 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States10 sites
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, 35294
Private Practice
Denver, Colorado, 80209
Valley Research
Fresno, California, 93720
University of Miami, Miller School of Medicine, Diabetes Research Institute
Miami, Florida, 33136
Creighton Diabetes Center
Omaha, Nebraska, 68131
Diabetes and Glandular Disease Center
San Antonio, Texas, 78229
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101-2795
MedStar Research Institute
Washington D.C., District of Columbia, 20003
Private Practice
Wellington, Florida, 33414
Australia4 sites
Fremantle Hospital
Fremantle, Western Australia, 6160
Peninsula Clinical Research Centre
Kippa-Ring, Queensland, 4021
Royal Melbourne Hospital
Parkville, Victoria, 3050
Eastern Clinical Research Unit
Ringwood East, Victoria, 3050
New Zealand4 sites
Christchurch Hospital
Christchurch, Canterbury, Private Bag 4710
Waikato Regional Diabetes Service
Hamilton, Waikato Region, Private bag 3200
The Diabetes Centre
Newtown, Wellington Region, Private Bag 7902
Middlemore Hospital
Otahuhu, Auckland, Private Bag 93311
About this 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
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.
Read the 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.
- Conditions
- Diabetes, Hypoglycemia
- Being tested
- BHT-3021, BHT-Placebo
- Keywords
- Diabetic, Diabetes, Type 1 Diabetes, Type 1 Diabetes Mellitus, autoimmune disease
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia, Diabetes Mellitus, Type 1, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHT-3021Drug
Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
BHT-PlaceboDrug
Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BHT-3021 Receives: Drug: BHT-3021 |
| 2 | Placebo comparator | BHT-Placebo Receives: Drug: BHT-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startOct 2006
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayhill Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Gottlieb, MD, Study chair, University of Colorado, DenverJoanne Quan, MD, Study director, Bayhill Therapeutics Inc.Len Harrison, MD, Study chair, Walter and Eliza Hall Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453375
- Sponsor's protocol ID
- BHT-3021-01
- Status last verified
- Jan 2011
- First submitted
- 26 Mar 2007
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00453375
- Acronym / sponsor ID
- BHT-3021-01
- Conditions
- Diabetes, Hypoglycemia
- Keywords
- Diabetic, Diabetes, Type 1 Diabetes, Type 1 Diabetes Mellitus, autoimmune disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bayhill TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BHT-3021BHT-3021 |
| 2 | Placebo comparator | Drug: BHT-PlaceboBHT-Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHT-3021Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks. | Drug | 1 |
| BHT-PlaceboEvaluation of up to four dose levels will be given in weekly IM injections for 12 weeks. | Drug | 2 |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Gottlieb, MD study chair
University of Colorado, Denver
Joanne Quan, MD study director
Bayhill Therapeutics Inc.
Len Harrison, MD study chair
Walter and Eliza Hall Institute of Medical Research
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BHT-3021 in people with Diabetes and Hypoglycemia, run by Bayhill Therapeutics at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.