Clinical study to Evaluate Efficacy and Safety of EL/DM/01 in participants with Type 2 Diabetes mellitus. - NI

Emil Pharmaceutical Industries Private Limited,0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

暂无简介。

•1. Patients diagnosed with type 2 diabetes mellitus and are taking oral hypoglycemic agents on regular basis
•1. Patients newly diagnosed with type II diabetes mellitus (newly diagnosed cases will be considered as those who have been diagnosed for diabetes mellitus for not more than one year) and those who are not on any oral hypoglycemic agent/insulin
•For Both the Cohorts:
•2.Patients having HbA1C value between 6.5 to 9.5 percent (both inclusive) at screening.
•3.Patients having Fasting Plasma Glucose between 126 to 250 mg per dl (both inclusive) at screening.
•4.Patients having postprandial glucose not more than 350 mg per 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 greater 2 years post menopause.
•7. Patients willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.

•For Both Cohorts:
•1. Patients suffering from type-1 DM or types of Diabetes mellitus other than Type-2
•2. Patients taking Insulin for the management of Diabetes
•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 product within 1 month prior to randomization
•10. Known history of hypersensitivity to ingredients used in study product
•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

发起方

Emil Pharmaceutical Industries Private Limited,