Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Vildagliptin and Metformin: Vildagliptin 100 mg SR + Metformin 500 mg /1000 mg SR tablet to be taken once in a day. The total duration of treatment period will be 90 days (from time of
Sponsors
D Y Patil University School of Medicine
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 years of age. 2. Males and females. 3. Patients having T2DM as per the criteria by the ADA with any one of the following two - Treatment naïve patients of T2DM, OR - Known patients of T2DM uncontrolled by existing anti-diabetic therapy.
Exclusion criteria
Exclusion criteria: 1. Type-1 diabetes mellitus. 2. Gestational diabetes. 3. Pancreatic Diabetes or Diabetes in the Context of Disease of the Exocrine Pancreas. 4. Post-transplantation Diabetes Mellitus. 5. Any reported evidence of malignancy. 6. Reports suggestive of any metabolic diseases. 7. Patients with moderate or severe renal impairment or with end-stage renal disease (ESRD) 8. Patients with hepatic impairment 9. Previously known hypersensitivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in HbA1C (%) from baseline to day 90. 2. Reduction in fasting plasma glucose (F-PG) from baseline to day 90. 3. Reduction in post-prandial plasma glucose (PP-PG) from baseline to day 90. Timepoint: Baseline-Visit 1 (Day 1), Visit 2 (Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| Global assessment by treating doctors on patient compliance with medication.Timepoint: Baseline-Visit 1 (Day 1), Visit 2 (Day 90);Physiciansâ?? assessment on product tolerability.Timepoint: Baseline-Visit 1 (Day 1), Visit 2 (Day 90);Proportion of patients who require additional oral antidiabetic drug (OAD) while on combination therapy with metformin plus vildagliptin.Timepoint: Baseline-Visit 1 (Day 1), Visit 2 (Day 90);Reduction in HbA1C (%) from baseline to day 90.Timepoint: Baseline-Visit 1 (Day 1), Visit 2 (Day 90);The percentage of patients who report adverse events during the study period. Timepoint: Baseline-Visit 1 (Day 1), Visit 2 (Day 90);Time to need for additional drug requirement.Timepoint: Baseline-Visit 1 (Day 1), Visit 2 (Day 90) | — |
Countries
India
Contacts
Public ContactDr Deepak Langade
D Y Patil University School of Medicine
Outcome results
None listed