A Double blind, Multi-center, Randomized, Prospective, Interventional, Placebo controlled, Clinical study to Evaluate Efficacy and Safety of Yesaka Plus Tablets in patients diagnosed with Type 2 Diabetes mellitus
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- 1.Change in HbA1C% (Glycosylated Hemoglobin) over a period of three months and between the groups
研究概览
简要总结
Itis a double blind, multi-center, randomized, prospective, interventional, placebocontrolled, clinical study to evaluate efficacy and safety of Yesaka PlusTablets in patients diagnosed with Type 2 Diabetes mellitus. The study will beconducted at 4 centers in India. Asper computer generated randomization list, subjects will be either randomizedto Yesaka Plus Tablets group or Placebo Tablet group in 1:1 ratio. Subjectswill be asked to consume given medication in a dose of 2 tablets twice daily orallyafter meals with water for 90 days. The primary objectives of the study will beto assess change in HbA1C% (Glycosylated Hemoglobin) over a period of threemonths and between the groups and change in FBS and PPBS on monthly basis over90 days (Before and after treatment) and between the groups. The secondaryobjectives will be to assess change in Fasting Serum Insulin, change in HOMA-IRscore, change in clinical symptoms of Type 2 DM, difference in the number ofrescue medication required by each group, monthly change in weight and BMI, change in quality of life assessed on QOLID, changein global assessment for overall change by subject and investigator, tolerabilityof study drugs and change in Laboratory parameters on day 0, day 30, day 60, day 90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients diagnosed with type 2 diabetes mellitus for not more than one year and those are not on any oral hypoglycemic agent/insulin (regular basis).
- •2.Patients having HbA1C value between 6.5-8.5% (both inclusive) at screening.
- •3.Patients having Fasting Plasma Glucose between 126 -250 mg/dl (both inclusive) at screening.
- •4.Patients having postprandial glucose not more than 350 mg/dl at screening 5.Patient’s ECG does not demonstrate any signs of uncontrolled arrhythmia / acute ischemia.
- •6.A negative urine pregnancy test for all female patients unless patient has had a hysterectomy, tubal ligation, or is > 2 years post menopause.
- •7.Patients willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.
排除标准
- •1.Patients already on regular OHAs or on insulin therapy.
- •2.Patients suffering from type-1 DM or types of Diabetes mellitus other than Type-2 3.Patients with known history of chronic hepatic or renal disease.
- •4.Patients with known history of malignancy.
- •5.Patients with known history of significant cardiovascular event 12 weeks prior to randomization.
- •6.Patients with known history of major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
- •7.Patients with known history of chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •8.Patients with known history of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
- •9.History of Use of any other investigational drug within 1 month prior to randomization 10.Known history of hypersensitivity to ingredients used in study drug 11.Pregnant and Lactating females.
- •12.Any other conditions which in the opinion of investigator will place the Patients at risk or will influence the conduct of study or interpretation of results.
结局指标
主要结局
1.Change in HbA1C% (Glycosylated Hemoglobin) over a period of three months and between the groups
时间窗: Day -7, Day 0, Day 30, Day 60, Day 90
2.Change in FBS and PPBS on monthly basis over 90 days (Before and after treatment) and between the groups
时间窗: Day -7, Day 0, Day 30, Day 60, Day 90
次要结局
- 1.Change in Fasting Serum Insulin.(2.Change in HOMA-IR score)