Type1 Diabetes MellitusPhase 1/2NCT04102202
BOL-DP-o-05 as an Add-On Treatment of Subjects With Newly Diagnosed Type 1 Diabetes Mellitus
A Phase 1/2 study testing BOL-DP-o-05 in people with Type1 Diabetes Mellitus, run by Breath of Life International Pharma Ltd.
Trial summary
BOL-DP-o-05 as an Add-On Treatment for Preservation of Beta-Cell Function in Subjects With Newly-Diagnosed Type 1 Diabetes Mellitus (T1DM) Read more about this study
- Who is it for?
- Ages 5 to 30 years
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- BOL-DP-o-05
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2020to 22 Mar 2021
- Phase
- Phase 1/2
- 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 5 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed consent obtained before any trial-related activities.
- T1DM ≤ 20 weeks prior to screening.
- Male or female, aged 5-30 years old (both inclusive) at the time of signing the informed consent form.
- Non-fasting peak C-peptide ≥0.2 nmol/l during mixed-meal tolerance test (MMTT) at Visit 1.
- BMI ≥18.5 kg/m2.
- Presence of one or more islet-specific autoantibodies at the screening.
- Insulin dependence, unless in temporary spontaneous remission ("honeymoon period").
Who cannot join
- Daily insulin usage > 1 U/kg per day at screening
- History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections.
- History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy.
- Vaccination within 4 weeks before randomization.
- Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening.
- History of pancreatitis (acute or chronic).
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- Any past or current diagnosis of malignant neoplasms.
- Known impairment of the immune system, except for T1DM, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease), and vitiligo.
- Patients with a psychiatric condition (e.g. severe anxiety, psychosis) that would interfere with the study as determined by the primary investigator.
- Patients with known allergy to one or more of the study drug components.
- Female patients who are pregnant, lactating, or who want to get pregnant during the study period. In the case of young patients, the PI should raise this point with the patient/family.
- Male subjects who want their partner to get pregnant.
- Female of child-bearing potential who do not agree to utilize medically acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study unless the patient is young and the PI speaks with the patient/family and waived the criteria due to young age.
- Patients with a history of alcohol or any psychoactive substance abuse or dependence (including alcohol but excluding nicotine and caffeine).
- Patients with a first-degree family history of a psychiatric condition diagnosed at age<30 years.
- Patients with congestive heart failure or any other chronic disease.
- Patients with heart failure, psychotic state in the past, anxiety disorder, and heredity significant psychiatric inheritance in first-degree family relative, especially in patients younger than 30, and a history of addiction or drug abuse.
About this study
Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, Safety & Efficacy Trial of BOL-DP-o-05 as an Add-On Treatment for Preservation of Beta-Cell Function in Subjects With Newly-Diagnosed T1DM
BOL-DP-o-05 as an Add-On Treatment for Preservation of Beta-Cell Function in Subjects With Newly-Diagnosed Type 1 Diabetes Mellitus (T1DM)
Read the detailed description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups study in which subjects will be randomized to receive either BOL-DP-o-05 or placebo as an Add-On Treatment. The study evaluates the effect of BOL-DP-o-05 for Preservation of Beta-Cell Function in Subjects with Newly-Diagnosed Type 1 Diabetes Mellitus (T1DM). The study includes a screening period up to three weeks followed by a 48-week treatment period
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- BOL-DP-o-05, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOL-DP-o-05Drug
BOL-DP-o-05
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BOL-DP-o-05 | Experimental | Not described Receives: Drug: BOL-DP-o-05 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of BOL-DP-o-05 on preservation of beta-cell function
Plasma levels of C-peptide concentration
Measured: up to week 48
Secondary outcomes (9)
Number of diabetic ketoacidosis episodes
Urine and plasma levels for ketones
Measured: Through study completion, an average of 48 weeks
Number of severe hypoglycaemic episodes
Plasma glucose level
Measured: Through study completion, an average of 48 weeks
Peak MMTT stimulated C-peptide concentration
Plasma levels of C-peptide concentration
Measured: Base line and week 48
To assess the change in fasting C-peptide
Plasma levels of C-peptide concentration
Measured: Baseline to week 24 and week 48
To assess the change in HbA1c
HbA1c in plasma
Measured: Baseline to weeks 24 and 48
To evaluate total daily insulin dose
Insulin levels in units per kg
Measured: Week 24 and week 48
To Assess the percentage of patients that maintain stimulated peak C-peptide ≥ 0.2nmol/L
Plasma levels of C-peptide
Measured: At week 48
To Assess the percentage of patients that achieve glycemic target of HbA1c ≤ 7.5%
HbA1c in plasma
Measured: At week 24 and week 48
To assess the percent of subjects who require a daily insulin dose < 0.5 IU/kg body weight
Plasma glucose levels
Measured: After 12 months of first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start15 Nov 2020 (estimated)
- Primary completion22 Mar 2021 (estimated)
- Study completion22 Mar 2021
Why it stopped: Due to company strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 Diabetes MellitusStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Breath of Life International Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102202
- Sponsor's protocol ID
- BOL-P-023
- Status last verified
- Mar 2021
- First submitted
- 15 Sep 2019
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, Safety & Efficacy Trial of BOL-DP-o-05 as an Add-On Treatment for Preservation of Beta-Cell Function in Subjects With Newly-Diagnosed T1DM
- ClinicalTrials.gov ID
- NCT04102202
- Acronym / sponsor ID
- BOL-P-023
- Conditions
- Type1 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to company strategic decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Breath of Life International Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2020 (estimated)
- Primary completion
- 22 Mar 2021 (estimated)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 25 Sep 2019 (actual)
- 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.
BOL-DP-o-05 as an Add-On Treatment for Preservation of Beta-Cell Function in Subjects With Newly-Diagnosed Type 1 Diabetes Mellitus (T1DM)
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups study in which subjects will be randomized to receive either BOL-DP-o-05 or placebo as an Add-On Treatment. The study evaluates the effect of BOL-DP-o-05 for Preservation of Beta-Cell Function in Subjects with Newly-Diagnosed Type 1 Diabetes Mellitus (T1DM). The study includes a screening period up to three weeks followed by a 48-week treatment period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOL-DP-o-05 | Experimental | Drug: BOL-DP-o-05 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 5 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Informed consent obtained before any trial-related activities.
- T1DM ≤ 20 weeks prior to screening.
- Male or female, aged 5-30 years old (both inclusive) at the time of signing the informed consent form.
- Non-fasting peak C-peptide ≥0.2 nmol/l during mixed-meal tolerance test (MMTT) at Visit 1.
- BMI ≥18.5 kg/m2.
Key exclusion criteria (17 listed)
- Daily insulin usage > 1 U/kg per day at screening
- History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections.
- History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy.
- Vaccination within 4 weeks before randomization.
- Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening.
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 |
|---|---|---|
| BOL-DP-o-05BOL-DP-o-05 | Drug | BOL-DP-o-05 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
To evaluate the effect of BOL-DP-o-05 on preservation of beta-cell function
Time frame: up to week 48
Plasma levels of C-peptide concentration
9 secondary outcomes
Number of diabetic ketoacidosis episodes
Time frame: Through study completion, an average of 48 weeks
Number of severe hypoglycaemic episodes
Time frame: Through study completion, an average of 48 weeks
Peak MMTT stimulated C-peptide concentration
Time frame: Base line and week 48
To assess the change in fasting C-peptide
Time frame: Baseline to week 24 and week 48
To assess the change in HbA1c
Time frame: Baseline to weeks 24 and 48
To evaluate total daily insulin dose
Time frame: Week 24 and week 48
To Assess the percentage of patients that maintain stimulated peak C-peptide ≥ 0.2nmol/L
Time frame: At week 48
To Assess the percentage of patients that achieve glycemic target of HbA1c ≤ 7.5%
Time frame: At week 24 and week 48
To assess the percent of subjects who require a daily insulin dose < 0.5 IU/kg body weight
Time frame: After 12 months of first treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BOL-DP-o-05 in people with Type1 Diabetes Mellitus, run by Breath of Life International Pharma Ltd.
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 7 inclusion and 17 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: withdrawn, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
To evaluate the effect of BOL-DP-o-05 on preservation of beta-cell function (time frame: up to week 48). 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 24 Mar 2021.