Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Metformin, Vildagliptin and Zinc: Metformin 500 mg and Vildagliptin 50 mg- BD With Zinc 25 mg OD, orally for 36 weeks
Control Intervention1: Metformin and Vildagliptin: Metformin 500 mg
Sponsors
ANJALY MARY VARGHESE
Eligibility
Inclusion criteria
Inclusion criteria: Patients who are newly diagnosed as suffering from Type 2 Diabetes mellitus not on any oral hypoglycemic agent. Patients with HbA1c between (7.0-9.5%), fasting glucose levels of above 126mg per dl or random blood glucose above or equal to 200mg/dl. Patients willing to participate in the trial, ready to abide by trial procedures and willing to give written informed consent.
Exclusion criteria
Exclusion criteria: Patients with active liver (more than 3 fold rise in ALT/AST) or kidney diseases, malignancies, neurological diseases, endocrine disorders, autoimmune diseases, and cardiovascular diseases. Uncontrolled hypertension (with systolic blood pressure: =180 mm Hg/diastolic blood pressure: =100 mm Hg). Smokers/ Alcoholics. Pregnant / lactating women. Acute pancreatitis, cystic fibrosis, hemochromatosis. Patient having known hypersensitivity to the study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target FBS, PPBS and HbA1cTimepoint: 12, 24, 36 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse drug events Patient complianceTimepoint: 12, 24, 36 weeks | — |
Countries
India
Contacts
Public ContactANJALY MARY VARGHESE
Rama Medical College Hospital and Research Centre
Outcome results
None listed