A Double-blind, Randomized Placebo Controlled Study to Evaluate the Effect of BioK+ 50B® on Glycemic Control in a Type 2 Diabetes Population
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Type2 Diabetes
- Sponsor
- Bio-K Plus International Inc.
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Change in HbA1c levels from baseline
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will be conducted at the Montreal Heart Institute and should involve 130 Type 2 diabetes subjects. Subjects will be randomized in a 1:1 ratio to receive either Bio-K+50B® probiotic capsules or a matching placebo.
Detailed Description
This is a phase 2 double-blind, randomized, single-center, placebo-controlled, parallel-group 12-week study of Bio-K+ probiotic 50B® in subjects diagnosed with Type 2 diabetes (T2D) and suboptimal glycemic control. After providing informed consent and completion of screening baseline assessments, approximately 130 subjects will be randomized in a 1:1 ratio to receive either Bio-K+50B® probiotic or matching placebo. Subjects will take investigational product or placebo once daily orally for 12 weeks. During the double-blind treatment period, subjects will complete a daily diary and will be contacted via telephone (at Week 4 and Week 8) for an assessment of adverse events, concomitant medications, diabetes management habits, collection of stool sample at home, diary revision and study product compliance. At visit 3 (Week 12; end of study visit) subjects will return to the study site for laboratory tests and clinical assessment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet ALL of the following inclusion criteria in order to be eligible for this study:
- •Aged 18 years and older on the day of consent;
- •T2D diagnosis according to Canadian diabetes guidelines\[24\] and treated with medication for this diagnosis;
- •Suboptimal glycemic control, as evidenced by HbA1c \>7%;
- •Body Mass Index (BMI); greater than or equal to 25 and less than 40 kg/m2
- •Subjects willing to maintain a stable diet and physical activity level throughout the study;
- •Ability and willingness to give written informed consent and to comply with the requirements of the study.
- •The subject is able to read and write English or French.
Exclusion Criteria
- •A patient who meets any of the following criteria will NOT be eligible to the study:
- •Subjects unlikely to cooperate in the study;
- •Legal incapacity or limited legal capacity;
- •Women who are pregnant, planning to become pregnant during the study or breast-feeding. Women of childbearing potential must have a negative urine pregnancy test at screening. Women are considered not of childbearing potential if they:
- •Have had a hysterectomy or tubal ligation prior to Visit
- •Are postmenopausal defined as no menses for 12 months or a Follicle-stimulating Hormone (FSH) level in the menopausal range.
- •Women of childbearing potential must agree to use an effective method of birth control throughout the study. Acceptable means of birth control include: implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, diaphragm with spermicide, male or female condoms with spermicide or cervical cap, abstinence, or a sterile sexual partner.
- •Participation in a drug or device trial within the previous 30 days (or within 5 half-lives of the investigational drug, or within the time legally required by local regulatory authorities, whichever is the longest) or participation in such trial considered, or patient already enrolled in the study. Participation to observation registries is allowed;
- •Type 1 diabetes;
- •Gestational diabetes;
Outcomes
Primary Outcomes
Change in HbA1c levels from baseline
Time Frame: 12 weeks
The primary objective is to evaluate the effect of Bio-K+50B® on HbA1c level compared with placebo after 12 weeks of treatment in subjects with T2D and suboptimal glycemic control (HbA1c \>7% at baseline).
Secondary Outcomes
- Evaluation of the safety profile of 2 capsules of Bio-K+50B® (dosage of 100 billions bacterias)(12 weeks)
- Evaluation of the effects of Bio-K+50B® as compared with placebo after 12 weeks of treatment on different biochemical markers:(12 weeks)
- Evaluation of the intestinal colonisation effects with the 2 capsules of Bio-K+50B® (dosage of 100 billions bacterias) as compared with placebo(12 weeks)