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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00453375




Registration number
NCT00453375
Ethics application status
Date submitted
26/03/2007
Date registered
28/03/2007
Date last updated
28/06/2011

Titles & IDs
Public title
Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus
Scientific 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
Secondary ID [1] 0 0
BHT-3021-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Hypoglycemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BHT-3021
Treatment: Drugs - BHT-Placebo

Experimental: 1 - BHT-3021

Placebo Comparator: 2 - BHT-Placebo


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

Treatment: Drugs: BHT-Placebo
Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Peninsula Clinical Research Centre - Kippa Ring
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [3] 0 0
Eastern Clinical Research Unit - Ringwood East
Recruitment hospital [4] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment postcode(s) [3] 0 0
3050 - Ringwood East
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
New Zealand
State/province [10] 0 0
Canterbury
Country [11] 0 0
New Zealand
State/province [11] 0 0
Waikato
Country [12] 0 0
New Zealand
State/province [12] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayhill Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00453375
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Gottlieb, MD
Address 0 0
University of Colorado, Denver
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00453375