Efficacy and safety of IDM1 in patients with type II Diabetes Mellitus on treatment with Sulphonylurea (double blind, placebo controlled, randomized, phase III, multi-centric study)

Indus Biotech Private Limited0 个研究点目标入组 78 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. Signed informed consent form
•2. Type II (non insulin dependent) diabetic patients
•3. Fasting plasma glucose between 140 mg/dl and 250 mg/dl (both inclusive)
•4. Fasting plasma glucose between 140 mg/dl and 250 mg/dl (both inclusive) that does not vary more than 30 mg/dl during fifteen days run in period
•5. HbA1c 7.0 to 12% both inclusive
•6. Body mass index 22 to 35 both inclusive
•7. Stabilised at same dose of medication (sulphonylurea) for a minimum period of six weeks
•8. No history of nephropathy/ketourea
•9. No history of HIV
•10. Pregnancy test negative
•11. No participation in any other trial during past 30 days
•12. No history of allergy to the ingredients or plant products or derivatives

•1. Patients above 71 years
•2. Patients treated with a drug within last 30 days that has not received regulatory approval at the time of study entry
•3. Participation in clinical study during past 30 days
•4. Fasting plasma glucose more than or equivalent to 251 mg/dl
•5. LFT (ALT/AST) > 2.5 times the upper limit of normal values
•6. Requiring a dose of insulin or surgery or other indication
•7. History of HIV
•8. Creatinine more than or equal to 1.5 mg/dl
•9. Pregnant or intend to become pregnant during the study or not actively practicing birth control measures or breast feeding
•10. Retinopathy/& nephropathy with persistent macro-albuminuria
•11. Patients classified as class III, or class IV heart diseases
•12. Abnormal laboratory values revealed on the analysis on baseline visit
•13. Patients with clinical signs and symptoms of drug or alcohol abuse
•14. Patients undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer

发起方

Indus Biotech Private Limited