Randomized, controlled study to assess the efficacy & safety of Diabetone tablet along with Cinafen plus tablet in subjects with Diabetes Mellitus. - Nil

Meyer Organics Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1.Adults (age 30 to 70) both sex with BMI more than or equal to 19.00 kg/m2.
•2.Patients with Metformin as an oral hypoglycemic agents as on-going or planned treatment for Type 2 Diabetes Mellitus since not more than 2 years from date of screening. Subjects willing to replace Metformin with investigational products if to be randomized in treatment group (Group A) in the study.
•3.Hemoglobin A1c (HbA1c) more than 5.7 % and less than 7.5%.
•4.Fasting Plasma Glucose (FPG) more than or equal to 90 mg/dL and less than or equal to 250 mg/dL.
•5.Subjects with symptoms as mentioned in study protocol (At least one) prevalent at the time of screening for the study.

•1.Subjects with Type 1 diabetes.
•2.Subjects under Insulin treatment.
•3.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >1.5 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine >1.4 mg/dl) as per discretion of investigator.
•4.Known case of uncontrolled pulmonary dysfunction or other active pulmonary infections as per discretion of investigator.
•5.Pregnant or lactating women.
•6.Smokers/Alcoholics and/or drug abusers.
•7.Patients with known history or ongoing malignancy.
•8.Patients suffering from major systemic illness necessitating medical care.
•9.Any other reason which can affect the participation of the subject in the study as per investigatorÃ¢â?¬•s discretion.

发起方

Meyer Organics Pvt Ltd