Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Sponsors
Welex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects suffering from type 2 diabetes mellitus for more than one year, and taking mono / poly drug oral hypoglycemic agent(s) for at least last 3 months. 2.Subjects having HbA1C value 6-10% (both inclusive) at screening. 3.Subjects having Fasting Plasma Glucose between 126 -250 mg/dl (both inclusive) at screening. 4.Subjects having postprandial glucose not more than 350 mg/dl at screening. 5.Subjectâ??s ECG not demonstrating any signs of uncontrolled arrhythmia / acute Ischemia and X- ray chest not showing any active lesion of tuberculosis. 6.A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is greater than 2 years post menopause.
Exclusion criteria
Exclusion criteria: 1.Patients on insulin therapy. 2.Patients suffering from type-1 DM or types of Diabetes mellitus other than Type-2 3.Patients with known history of chronic hepatic or renal disease. 4.Patients with known history of active malignancy. 5.Patients with known history of significant cardiovascular event & lt; 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 drug within 1 month prior to randomization. 10.Known history of hypersensitivity to ingredients used in study drug. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Assessment of change in dose of OHA(s) over a period of three months. 2.Assessment of change in Quality of life of patient over three months of treatment. Timepoint: Day 0, Day 30, Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of changes in fasting & postprandial plasma glucose levels. 2.Assessment of changes in post treatment HbA1C % 3.Assessment of changes in post treatment Serum Insulin level. 4.Assessment of changes in clinical symptoms of Type 2 DM 5.Assessment of level of energy, stamina and physical strength 6.Assessment of level of stress. 7.Global assessment for overall improvement 8.Assessment of tolerability of study drugs. 9.Assessment of Laboratory parameters. Timepoint: Day 0, Day 30, Day 60, Day 90 | — |
Countries
India
Contacts
Public ContactVandana Bade
Target Institute of Medical Education and Research
Outcome results
None listed