A double blind, randomized, placebo controlled study to determine the safety and efficacy of UB 0316 as an adjuvant for 12 weeks in type 2 diabetes mellitus.

nique Biotech Ltd0 个研究点目标入组 79 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Male or female outpatient between the ages of 18- 65 years.
•2.Subject states that he/she has type 2 diabetes (as evidenced by use of stable metformin monotherapy medication for at least 8 weeks prior to screening).
•3.Subject has an HbA1c level >= 7 % & <= 9%
•4.Subjectâ??s BMI is > 23 kg/m2 and < 32 kg/m2
•5.If on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least six months prior to screening visit.
•6.Female, not currently pregnant or breast feeding and are using mechanical contraceptive devices such as Intra-uterine devices (IUD). (Barrier method of birth control; abstinence) prior to entry into study, during the period of study participation.
•7.Ability to understand and the willingness to sign and date a written Informed Consent document at the screening visit before any protocol specific procedures are performed

•1.Subject states that he/she has type 1 diabetes.
•2.Subject states that he/she has history of diabetic ketoacidosis.
•3.Subject uses anti-hyperglycemic medication other than metformin for glucose control.
•4.Subject has fasting blood triglycerides > 400 mg/dL and/or LDL cholesterol > 190 mg/dL at screening.
•5.Subject has an HbA1c level > 9.0% at screening.
•6.Known hypersensitivity to any of the study drugs or constituents.
•7.Subjects suffering from severe systemic disease.
•8.Subjects receiving any Ayurvedic, Homeopathic or Herbal drug continuously for one month; in last 30 days during screening visit.

发起方

nique Biotech Ltd