A phase 2, randomized, double blind, parallel group placebo controlled single centric study to evaluate the anti-diabetic potential of ARLPK01 as an add on therapy with metformin in patients with type 2 diabetes mellitus.

ARVIND REMIDIES LTD0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•Both gender
•Age 30-55 years.
•Patients whose duration of Type 2 Diabetes mellitus for 0-8years.
•Patients with stable dose of metformin for atleast 3 months.
•Patients with fasting glucose level <130mg/dl and Postprandial glucose level <250mg/dl
•Patients with HbA1c between 7.0-8.5 %.
•Patients ready to abide by trial procedures and to give informed consent.

•Type 1 Diabetes mellitus and Gestational Diabetes Mellitus.
•Patients with HbA1c more than 8.5 %.
•Complications of diabetes such as Diabetic retinopathy, Diabetic Neuropathy and Diabetic Nephropathy.
•Patients with Cardiovascular Disorders, kidney and liver complications
•Ischemic heart disease with any cardiac event in last 6 months.
•Patients who are likely to undergo surgery during the study period.
•Patients who have participated in any investigational study in the last 8 weeks.
•Patients having known hypersensitivity to the study drugs and Patients with any severe infection .
•Patients with a history of intake of any Ayurvedic /herbal/homeopathic or any alternative therapies in the last one month.
•Pregnant or lactating females.
•Any clinical relevant abnormal physical or laboratory findings at the screening examination as judged by the investigator which would interfere with the objectives of the study.

发起方

ARVIND REMIDIES LTD