Health Condition 1: null- Diabetes mellitus type 2
Conditions
Interventions
Intervention1: UB-0316: 2 UB0316 capsules/per orum/per day for 12 Weeks
Control Intervention1: Placebo: 2 capsules/per orum/per day for 12 Weeks
Sponsors
Unique Biotech Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female outpatient between the ages of 18- 65 years. 2.Subject states that he/she has type 2 diabetes (as evidenced by use of stable metformin monotherapy medication for at least 8 weeks prior to screening). 3.Subject has an HbA1c level >= 7 % & 4.Subjectâ??s BMI is > 23 kg/m2 and 5.If on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least six months prior to screening visit. 6.Female, not currently pregnant or breast feeding and are using mechanical contraceptive devices such as Intra-uterine devices (IUD). (Barrier method of birth control; abstinence) prior to entry into study, during the period of study participation. 7.Ability to understand and the willingness to sign and date a written Informed Consent document at the screening visit before any protocol specific procedures are performed
Exclusion criteria
Exclusion criteria: 1.Subject states that he/she has type 1 diabetes. 2.Subject states that he/she has history of diabetic ketoacidosis. 3.Subject uses anti-hyperglycemic medication other than metformin for glucose control. 4.Subject has fasting blood triglycerides > 400 mg/dL and/or LDL cholesterol > 190 mg/dL at screening. 5.Subject has an HbA1c level > 9.0% at screening. 6.Known hypersensitivity to any of the study drugs or constituents. 7.Subjects suffering from severe systemic disease. 8.Subjects receiving any Ayurvedic, Homeopathic or Herbal drug continuously for one month; in last 30 days during screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary outcome is change in hemoglobin A1c from baseline to week 12Timepoint: 1. The primary outcome is change in hemoglobin A1c from baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in blood glucose levels from baseline to week 12 2. Change in fasting blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, VLDL cholesterol, triglycerides) from baseline to week 12 3. Change in body weight from baseline to week 12 4. Change in Quality of Life (QOL) from baseline to week 12 5. Change in insulin levels from baseline to week 12 7. Change in HOMA-IR from baseline to week 12. Timepoint: 1. Change in blood glucose levels from baseline to week 12 2. Change in fasting blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, VLDL cholesterol, triglycerides) from baseline to week 12 3. Change in body weight from baseline to week 12 4. Change in Quality of Life (QOL) from baseline to week 12 5. Change in insulin levels from baseline to week 12 7. Change in HOMA-IR from baseline to week 12. | — |
Countries
India
Contacts
Public ContactDr Jayanthi Neelamraju
Unique Biotech Ltd.
Outcome results
None listed