A Clinical Evaluation of Efficacy and Safety of Tablet DIABEPAL as an Add-on therapy with Oral Hypoglycemic Agent (OHA) in Type 2 Diabetic Patients - A Randomized, Single-center, Double Blind, Placebo Controlled Study - NI

Arjun Healthcare0 个研究点目标入组 80 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Subjects suffering from Type 2 Diabetes Mellitus for more than one year,
•2. Subject stabilized on mono/ polydrug anti-diabetic therapy for at least last 3 months.
•3. Subjects having their fasting blood glucose in the range of 126 -252 mg/dl on screening visit
•4. HbA1C in range of 7-11%
•5. Subjectâ??s ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia
•6. Subjects with controlled blood pressure and controlled lipid levels

•1.Subjects on insulin therapy
•2.Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type -2
•3.Subjects having known hepatic or renal disease
•4.Subjects having an active malignancy
•5.Subjects with history of significant cardiovascular event < 12 weeks prior to randomization
•6.Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds

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