Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Sponsors
Welex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects with newly diagnosed Type II Diabetes Mellitus or known case of Diabetes mellitus not more than one year 2. Subjects having HbA1c value between 6-8 % at screening (both inclusive). 3. Subjects having Fasting Plasma Glucose 125-250 mg/dl (both inclusive) and Postprandial glucose not more than 300 mg/dl at screening. 4. Subjects of female gender or non-pregnant, non-lactating females. A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy, tubal ligation, or is greater than 2 years Postmenopausal. 5. Subjects willing to follow the procedures as per the study protocol and Voluntarily signing informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects of Type 1 Diabetes. 2. Known cases of Severe/Chronic hepatic or renal disease. 3. Subject having any active malignancy. 4. Subjects giving history of significant cardiovascular event less than 12 weeks prior to screening. 5. Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds. 6. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 7. Subjects having active metabolic or gastrointestinal diseases that may interfere With nutrient absorption, metabolism, or excretion, excluding diabetes. 8. Subjects using any other investigational drug within 1 month prior to recruitment 9. Known hypersensitivity to any of the ingredients used in study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Assessment of changes in HbA1c % levels over 3 months 2. Monthly Assessment of changes in fasting and post- Prandial plasma glucose levelsTimepoint: Day 0, Day 30, Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of changes in Serum Insulin Levels 2. Assessment of quality of life (QOL) 3. Assessment of changes in the clinical symptoms of Diabetes Mellitus 4. Assessment of level of energy, stamina and physical strength 5. Assessment of level of stress 6. Assessment of Physicianâ??s Global evaluation for overall change. 7. Assessment of requirement of OHA. 8. Assessment of Adverse Drug Reaction and laboratory parameters. 9. Global assessment of overall safetyTimepoint: Day 0, Day 30, Day 60 and Day 90 | — |
Countries
India
Contacts
Public ContactVandana Bade
Target Institute of Medical Education and Research
Outcome results
None listed