A randomized, double-blind, parallel-arm clinical trial to assess the efficacy and safety of Berberine extract in participants with type 2 diabetes mellitus.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.Changes in Glycemic profile by assessing
研究概览
简要总结
T2DM is a chronic metabolic disorder characterized by insulin resistance and hyperglycemia, leading to various complications affecting multiple organ systems. Despite the availability of OHAs, achieving and maintaining glycemic control in T2DM patients remains a challenge. Therefore, there is a continuous need for novel therapeutic approaches that can effectively manage T2DM while minimizing adverse effects and improving patients’ quality of life.
Berberine, a plant-derived alkaloid, has shown promising effects in improving glycemic control and insulin sensitivity in preclinical and clinical studies. However, there is limited evidence from well-designed clinical trials assessing its safety and efficacy in T2DM patients, especially when used as an adjuvant to existing OHAs.
This randomized, double-blind, parallel arm, interventional, prospective clinical trial aims to address this gap in knowledge by evaluating the safety and efficacy of standardized extract of berberine supplementation in the management of T2DM. Investigating four different formulations of berberine i.e. Berbabsorb high dose- 1000mg, Berbabsorb low dose-750mg, Standardized extract of Berberine 500 mg, and Lipokon® Berberine 500 mg allow for dose-response evaluation and identification of the optimal therapeutic dose.
The study incorporates a wide range of outcome measures, including glycemic profile, insulin resistance, lipid metabolism, metabolic syndrome severity, anthropometric parameters, diabetes-related quality of life, and safety assessment. By examining multiple endpoints, the study provides a holistic evaluation of Berberine’s impact on various aspects of T2DM management.
This clinical trial addresses the need for evidence-based adjunctive therapies in T2DM management by investigating the efficacy and safety of Berberine extract. The study’s design, including dose optimization, enhances the robustness and reliability of the findings, ultimately contributing to informed clinical decision-making and improved patient outcomes in T2DM care.
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
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female participants between age 30-65 years (both inclusive);
- •Participants receiving oral hypoglycemic agents (OHA) biguanides and sulfonylureas (only combination) Newly diagnosed participants who are eligible for inclusion may begin the trial with investigational product monotherapy.
- •In the event of poor glycemic control, or safety concerns, the investigator may initiate standard-of-care treatment for type 2 diabetes mellitus;
- •Glycated haemoglobin (HbA1c) greater than 6.5% and less than 8% (both inclusive);
- •Fasting Plasma Glucose (FPG) greater than 130 mg/dL and less than 250 mg/dL (both inclusive);
- •Participants willing to comply with the study procedure and sign written informed consent;
- •Participants with a BMI of more than 28 and less than 35 kg/m2;
- •Participants with or without deranged lipid profile.
排除标准
- •1.Type 1 diabetes; 2.Receiving antidiabetic drugs except for those specified in the inclusion criteria including Insulin treatment; 3.Participants with concurrent serious hepatic dysfunction (defined as AST and/or ALT greater than 3 times of the upper normal limit) or renal dysfunction (defined as S.
- •creatinine greater than 1.4 mg/dl), uncontrolled pulmonary dysfunction (asthmatic and COPD patients) or other concurrent severe disease; 4.Participants suffering from major systemic illness necessitating long-term drug treatment including but not limited to hematologic conditions (eg, hemolytic anemias, sickle cell anemia), acute myocardial infarction, unstable angina, uncontrolled hypertension, congestive heart failure (class III or class IV NYHA), or cerebrovascular accident, psychiatric or neurological disorder, autoimmune condition, received chronic (grater than 14 days) therapy with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) within six months prior to enrollment; 5.Smokers or Alcoholics and or drug abusers; 6.Participants with evidence or history of malignancy; 7.Involvement in any other clinical trial requiring drug therapy; 8.Pregnant or lactating women or women of fertile age not using effective contraception; 9.Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.
结局指标
主要结局
1.Changes in Glycemic profile by assessing
时间窗: At Screening, Day 30, Day 60, Day 90.
a) Fasting, and post-meal plasma glucose levels
时间窗: At Screening, Day 30, Day 60, Day 90.
from screening to the end of the study and
时间窗: At Screening, Day 30, Day 60, Day 90.
b) HbA1c levels at screening and end of the
时间窗: At Screening, Day 30, Day 60, Day 90.
study.
时间窗: At Screening, Day 30, Day 60, Day 90.
2.Changes in Insulin resistance by assessing
时间窗: At Screening, Day 30, Day 60, Day 90.
Fasting insulin, HOMA-IR score at screening and
时间窗: At Screening, Day 30, Day 60, Day 90.
end of the study.
时间窗: At Screening, Day 30, Day 60, Day 90.
次要结局
- 1.Changes in lipid metabolism by assessing(cholesterol, LDL, HDL, Triglycerides etc., at)
研究者
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre and Hospital