Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Individuals more than 18 yrs of age. 2. Patients who had failed on monotherapy with metformin (1000 mg/day). 3. HbA1c >= 6.5%. 4. FPG >126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 hours. 5. PPPG >200 mg/dl (11.1 mmol/l) two hours after meals.
Exclusion criteria
Exclusion criteria: 1. Those patients requiring change in dose as per treating physician during study period will be excluded from the study. 2. Patient with renal disease. 3. Patient on insulin 6 months prior to screening. 4. Patients with any acute or chronic complication of diabetes mellitus. 5. Patients with infection 4 wks. prior to screening. 6. Patients on parenteral glucocorticoids, growth hormone. 7. Patient suffering from active or chronic hepatic disease. 8. Pregnant/ lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy, safety and effect on cardiovascular risk factors of metformin plus gliclazide versus metformin plus glimepiride in patients with type 2 diabetes mellitusTimepoint: 0 weeks, 6 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| not applicableTimepoint: not applicable | — |
Countries
India
Contacts
Dr. Vaishampayan Memorial Government Medical College