| Outcome Measures: |
Primary: Reduction in HbA1c from baseline, To confirm the efficacy of metformin+ insulin+ sitagliptin in controlling glycemia with respect to change from baseline in HbA1c after 24 weeks of administration. This will be accomplished by comparing the difference in change from baseline in HbA1c after 24 weeks of administration, compared with metformin+insulin+glimepiride to a non-inferiority limit of 0.3% , and if non-inferiority is proven, to a superiority limit of 0%., six months | Secondary: Change in total daily dose (TDD) of insulin, Change from baseline in insulin TDD (30-day geometric mean) at Month 6, 6 months|Episodes of hypoglycemia, Hypoglycemia (Total, severe, nocturnal) (From Month 0 to Month 6), as assessed by questionnaire and supplemented by SMBG values, if available, 6 months|Proportion of patients with HbA1c reduction, Proportion of patients, who completed treatment , with HbA1c value \<6.5% \& ≤7.3% at end of study (Month 6), 6 months|change in weight and BMI, 6 months|Change in both HbA1c and TDD, Proportion of patients achieving both HbA1c ≤6.5% AND reduction in TDD (total daily dose of insulin), 6 months|Change in insulin resistance and beta cell function, Change from baseline in c-peptide levels, homeostasis model assessments of β-cell function and insulin resistance (HOMA-β and HOMA-IR), 6 months|Change in lipid profile from baseline, 6 months
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