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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00453375