Triple oral fixed-dose diabetes polypill versus insulin plus metformin efficacy demonstration study in the treatment of advanced type 2 diabetes (TrIED study-II)

Abstract

When compared with suboptimally titrated IM there was a trend towards a lower HbA1c with GMP and significantly more GMP subjects obtained an HbA1c under 7%. Global assessments by investigators and subjects showed both a greater efficacy and tolerability with GMP.

Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

“…Advancing to triple combination therapy Some studies have shown advantages of adding a third non-insulin agent to a two-drug combination that is not yet or no longer achieving the glycaemic target [83][84][85][86]. Not surprisingly, however, at this juncture, the most robust response will usually be with insulin.…”

Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach: Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

“…Some studies have shown advantages of adding a third noninsulin agent to a twodrug combination that is not yet or no longer achieving the glycemic target. [83][84][85][86] Not surprisingly, however, at this juncture, the most robust response will usually be with insulin. Indeed, since diabetes is associated with progressive b-cell loss, many patients, especially those with long-standing disease, will eventually need to be transitioned to insulin, which should be favored in circumstances where the degree of hyperglycemia (e.g., ≥ 8.5%) makes it unlikely that another drug will be of sufficient benefit.…”

Comparison of efficacy of add-on therapy of vildagliptin versus pioglitazone among Type 2 Diabetes Mellitus patients inadequately controlled on dual therapy of metformin plus sulfonylurea

“…Roberts VL et al, 2005 found that the addition of glimepride significantly improved the glycemic control as compared to placebo with an acceptable tolerability profile, among patients with type 2 DM not adequately controlled by dual therapy of metformin and thiazolidinedione. 10 The results by Bell DS et al, 2011 show that a fixed dose triple oral diabetes polypill containing glimepride, metformin SR (500 mg) and pioglitazone (15 mg) led to a lower HbA 1c levels as compared to combination of human insulin 70/30 mix and 500 mg metformin among patients with type 2 DM inadequately controlled on combination of glimepride and metformin. 11 In a comparison using historical control, Hsia SH et al, 2011 compared the efficacy of sitagliptin 100 mg daily among patients with poorly controlled type 2 DM while taking maximum tolerated doses of metformin plus sulfonylureas, with historical control group of similar patients treated with rosiglitazone, 8 mg daily, or pioglitazone, 45 mg daily, as their third-line oral agent.…”

“…10 The results by Bell DS et al, 2011 show that a fixed dose triple oral diabetes polypill containing glimepride, metformin SR (500 mg) and pioglitazone (15 mg) led to a lower HbA 1c levels as compared to combination of human insulin 70/30 mix and 500 mg metformin among patients with type 2 DM inadequately controlled on combination of glimepride and metformin. 11 In a comparison using historical control, Hsia SH et al, 2011 compared the efficacy of sitagliptin 100 mg daily among patients with poorly controlled type 2 DM while taking maximum tolerated doses of metformin plus sulfonylureas, with historical control group of similar patients treated with rosiglitazone, 8 mg daily, or pioglitazone, 45 mg daily, as their third-line oral agent. Although, HbA 1c was reduced in both groups at four months (p < 0.001), the reduction of HbA 1c levels and the percentage of patients who achieved HbA 1c levels < 7.5% was greater with thiazolidinediones than with sitagliptin (p = 0.006 and p = 0.026).…”