BOL-DP-o-05 as an Add-On Treatment of Subjects With Newly Diagnosed Type 1 Diabetes Mellitus
Primary Purpose
Type1 Diabetes Mellitus
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BOL-DP-o-05
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type1 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- 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").
Exclusion Criteria:
- 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).
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BOL-DP-o-05
Placebo
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the effect of BOL-DP-o-05 on preservation of beta-cell function
Plasma levels of C-peptide concentration
Secondary Outcome Measures
Number of diabetic ketoacidosis episodes
Urine and plasma levels for ketones
Number of severe hypoglycaemic episodes
Plasma glucose level
Peak MMTT stimulated C-peptide concentration
Plasma levels of C-peptide concentration
To assess the change in fasting C-peptide
Plasma levels of C-peptide concentration
To assess the change in HbA1c
HbA1c in plasma
To evaluate total daily insulin dose
Insulin levels in units per kg
To Assess the percentage of patients that maintain stimulated peak C-peptide ≥ 0.2nmol/L
Plasma levels of C-peptide
To Assess the percentage of patients that achieve glycemic target of HbA1c ≤ 7.5%
HbA1c in plasma
To assess the percent of subjects who require a daily insulin dose < 0.5 IU/kg body weight
Plasma glucose levels
Full Information
NCT ID
NCT04102202
First Posted
September 15, 2019
Last Updated
March 22, 2021
Sponsor
Breath of Life International Pharma Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04102202
Brief Title
BOL-DP-o-05 as an Add-On Treatment of Subjects With Newly Diagnosed Type 1 Diabetes Mellitus
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Due to company strategic decision
Study Start Date
November 15, 2020 (Anticipated)
Primary Completion Date
March 22, 2021 (Anticipated)
Study Completion Date
March 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Breath of Life International Pharma Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BOL-DP-o-05
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BOL-DP-o-05
Intervention Description
BOL-DP-o-05
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
To evaluate the effect of BOL-DP-o-05 on preservation of beta-cell function
Description
Plasma levels of C-peptide concentration
Time Frame
up to week 48
Secondary Outcome Measure Information:
Title
Number of diabetic ketoacidosis episodes
Description
Urine and plasma levels for ketones
Time Frame
Through study completion, an average of 48 weeks
Title
Number of severe hypoglycaemic episodes
Description
Plasma glucose level
Time Frame
Through study completion, an average of 48 weeks
Title
Peak MMTT stimulated C-peptide concentration
Description
Plasma levels of C-peptide concentration
Time Frame
Base line and week 48
Title
To assess the change in fasting C-peptide
Description
Plasma levels of C-peptide concentration
Time Frame
Baseline to week 24 and week 48
Title
To assess the change in HbA1c
Description
HbA1c in plasma
Time Frame
Baseline to weeks 24 and 48
Title
To evaluate total daily insulin dose
Description
Insulin levels in units per kg
Time Frame
Week 24 and week 48
Title
To Assess the percentage of patients that maintain stimulated peak C-peptide ≥ 0.2nmol/L
Description
Plasma levels of C-peptide
Time Frame
At week 48
Title
To Assess the percentage of patients that achieve glycemic target of HbA1c ≤ 7.5%
Description
HbA1c in plasma
Time Frame
At week 24 and week 48
Title
To assess the percent of subjects who require a daily insulin dose < 0.5 IU/kg body weight
Description
Plasma glucose levels
Time Frame
After 12 months of first treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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").
Exclusion Criteria:
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).
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BOL-DP-o-05 as an Add-On Treatment of Subjects With Newly Diagnosed Type 1 Diabetes Mellitus
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