AN OPEN LABELED, DOUBLE ARM, RANDOMIZED, MULTICENTRIC, PROSPECTIVE, PHASE-III TRIAL TO COMPARE THE EFFICACY, TOLERABILITY AND SAFETY OF FIXED DOSE COMBINATION OF ALPHA-LIPOIC ACID AND METFORMIN WITH METFORMIN ALONE IN THE TREATMENT OF PATIENTS OF DIABETIC POLYNEUROPATHY.

M/S JENBURKT PHARMACEUTICALS LTD.0 个研究点目标入组 200 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。

•All patients with duly filled in ICFs [Informed Consent Forms]
•Ages: Eligible for Study: 18 - 60Years,
•Genders Eligible for Study: Both
•BMI ? Patients having BMI from 18-27%
•Patients with Type 2 Diabetes in whom Diabetes was inadequately controlled by diet alone.
•Fasting serum insulin < 15μIU/ mL and peak serum Insulin during Patients with HbA1clevel was >7 and <12%.
•Patients with fasting serum c-peptide of 0.333 pmol/ L.
•Patients with fasting serum glucose-to-insulin ration of > 4.5mg μIU/ mL.dL
•Patients who were taking Sulfonylurea or Metformin below the maximum dose as long as the antidiabetic drug was discontinued.

•Patients unwilling to sign on ICF.
•Patients with known history of sensitivity to ALA or Metformin.
•Patients with a history of lactic acidosis.
•Patients having received other investigational drugs within 2 weeks of therapy,
•Patients having received insulin treatment 30-days prior to the enrollment in the study.
•Patients having received glucocorticoid therapy within 4 weeks of therapy.
•Women using oral contraceptives that can affect insulin sensitivity
•Patients with Type 1 Diabetes.
•Patients having BMI > 27
•Patients with HbA1clevel was >12%
•Patients with major debilitating diseases.
•Patients with recent cardiovascular events.
•Patients with gastrointestinal diseases.
•Patients with significant renal impairment (blood urea nitrogen, >35 mg/dl; serum creatinine, >2.0 mg/dl; or creatinine clearance, <40 ml/min per 1.73 m2 of body surface area),
•Patients with severe hepatic disease.
•Pregnancy or breast-feeding.
•Any other serious diseases having fatal progression.

发起方

M/S JENBURKT PHARMACEUTICALS LTD.