CTRI/2024/03/063627尚未招募Phase 3 4
A Randomized, Double-Blind, Placebo-Controlled, Clinical Study to Evaluate the Efficacy of F-Bioticâ„¢ in Type 2 Diabetes Mellitus Subjects as an Adjuvant to Stable Metformin Therapy.
Arishina Life Sciences Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年3月11日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean change in Fasting blood sugar levels
研究概览
简要总结
This is a randomized (1:1), double-blind, two-arm, placebo-controlled, parallel group, clinical study. Type 2 Diabetes Mellitus (T2DM) subjects on stable metformin monotherapy medication for at least 8 weeks and meeting all inclusion and exclusion criteria will be screened in the study. After passing the eligibility criteria, subjects will be randomized to receive F-Bioticâ„¢ or placebo once a day, 30 minutes before meals for 12 weeks. Assessments as per the procotol will be performed at all visits. Blood samples will be collected for biomarker analysis and safety assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects diagnosed with Type 2 diabetes mellitus on stable metformin monotherapy for 8 weeks prior to the screening with: o Glycated hemoglobin (HbA1c) between greater than or equal to 6.6 and less than or equal to 9% o Fasting blood sugar greater than or equal to 126 mg per dl o BMI of 23-32 kg per meter square
- •Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test at screening.
- •Subject willing to adhere with their routine diet, physical activity, and general lifestyle throughout the study.
- •Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •Subjects diagnosed with Type 1 diabetes mellitus
- •Subjects currently on any medications or supplements other than metformin known to influence blood glucose concentration
- •Subjects with following levels at Screening visit o Fasting blood triglycerides greather than 400 mg per dL o Low density lipoprotein (LDL) greater than 190 mg per dL o HbA1c greater than 9%
- •Subjects with history of o Uncontrolled or serious medical illness including renal, liver disease, hypertension.
- •o Diabetes ketoacidosis o Cardiac disease or neurological problems o Auto-immune disease (rheumatoid arthritis, lupus, type 1 diabetes) o Gastrointestinal tract bleeding or peptic ulcer disease o Psychiatric disorders or Severe neurological diseases or seizures
- •Subjects who maybe allergic to any of the natural constituents of the Investigational Product
- •Known HIV or Hepatitis B positive or any other immuno-compromised state
- •Pregnant and lactating women
- •Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- •Any additional condition(s) that in the Investigators opinion that may interfere with subject treatment, assessment or compliance with the protocol and would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Mean change in Fasting blood sugar levels
时间窗: Baseline, Day 42, Day 84
次要结局
- Mean change in biochemical parameters and biomarkers(Baseline, Day 42, Day 84)
研究者
Dr Harshith C S
BGS Global Institute of Medical Sciences
研究点 (1)
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