BOL-DP-o-05 as an Add-On Treatment of Subjects With Newly Diagnosed Type 1 Diabetes Mellitus

NCT04102202 | Withdrawn Phase 1

• 1 other identifier: BOL-P-023
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of BOL-DP-o-05 on preservation of beta-cell function

  Plasma levels of C-peptide concentration

  up to week 48

Secondary Outcomes (9)

• Number of diabetic ketoacidosis episodes

  Through study completion, an average of 48 weeks

• Number of severe hypoglycaemic episodes

  Through study completion, an average of 48 weeks

• Peak MMTT stimulated C-peptide concentration

  Base line and week 48

• To assess the change in fasting C-peptide

  Baseline to week 24 and week 48

• To assess the change in HbA1c

  Baseline to weeks 24 and 48

Study Arms (2)

BOL-DP-o-05

EXPERIMENTAL

Drug: BOL-DP-o-05

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BOL-DP-o-05 DRUG

BOL-DP-o-05

BOL-DP-o-05

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 5 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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").

You may not qualify if:

• 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.

Sponsors & Collaborators

• Breath of Life International Pharma Ltd: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: September 25, 2019
• Study Start: November 15, 2020
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share