Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: For Both the COHORTS
Product: EL/DM/01: Dosage and treatment duration
2 Tablets twice daily orally after meals for 90 days
Control Intervention1: FOR BOTH THE COHORTS
Product: Placebo:
Sponsors
Emil Pharmaceutical Industries Private Limited,
Eligibility
Inclusion criteria
Inclusion criteria: Cohort 1 1. Patients diagnosed with type 2 diabetes mellitus and are taking oral hypoglycemic agents on regular basis Cohort 2 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in HbA1c percent (average change and proportion of subjects achieving target HbA1c levels below 6.5 percent). 2. Change in quality of life assessed on QOLID Timepoint: Day -7, day 0, day 30, day 60 and day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in FBS and PPBS (average change and proportion of subjects achieving target Fasting blood sugar of 110 mg per dl and PP blood sugar levels of 140 mg per dl). 2. Change in Fasting Serum Insulin 3. Change in HOMA-IR score 4. Change in clinical symptoms of Type 2 DM 5. Difference in requirement of Oral Hypoglycemic agents 6. Monthly change in weight and BMI 7. Change in global assessment for overall change by subject and investigator 8. Tolerability of study products 9. Change in Laboratory parameters Timepoint: Day -7, day 0, day 30, day 60 and day 90 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd.
Outcome results
None listed