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

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ClinicalTrials.gov Identifier: NCT04102202
Recruitment Status : Not yet recruiting
First Posted : September 25, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Breath of Life International Pharma Ltd

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)

Condition or disease Intervention/treatment Phase
Type1 Diabetes Mellitus Drug: BOL-DP-o-05 Drug: Placebo Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: BOL-DP-o-05 Drug: BOL-DP-o-05
BOL-DP-o-05

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of diabetic ketoacidosis episodes [ Time Frame: Through study completion, an average of 48 weeks ]
    Urine and plasma levels for ketones

  2. Number of severe hypoglycaemic episodes [ Time Frame: Through study completion, an average of 48 weeks ]
    Plasma glucose level

  3. Peak MMTT stimulated C-peptide concentration [ Time Frame: Base line and week 48 ]
    Plasma levels of C-peptide concentration

  4. To assess the change in fasting C-peptide [ Time Frame: Baseline to week 24 and week 48 ]
    Plasma levels of C-peptide concentration

  5. To assess the change in HbA1c [ Time Frame: Baseline to weeks 24 and 48 ]
    HbA1c in plasma

  6. To evaluate total daily insulin dose [ Time Frame: Week 24 and week 48 ]
    Insulin levels in units per kg

  7. To Assess the percentage of patients that maintain stimulated peak C-peptide ≥ 0.2nmol/L [ Time Frame: At week 48 ]
    Plasma levels of C-peptide

  8. To Assess the percentage of patients that achieve glycemic target of HbA1c ≤ 7.5% [ Time Frame: At week 24 and week 48 ]
    HbA1c in plasma

  9. 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 ]
    Plasma glucose levels



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102202


Contacts
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Contact: Moshe Phillip, M.D. +972 4795995 mosheph@clalit.org.il

Sponsors and Collaborators
Breath of Life International Pharma Ltd

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Responsible Party: Breath of Life International Pharma Ltd
ClinicalTrials.gov Identifier: NCT04102202     History of Changes
Other Study ID Numbers: BOL-P-023
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases