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Efficacy and safety of linagliptin/metformin single-pill combination as initial therapy in drug-naïve Asian patients with type 2 diabetes.

Abstract：

AIM:To assess efficacy/safety of initial linagliptin/metformin single-pill combination (SPC) therapies versus individual drug components over 24weeks in treatment-naïve Asian patients with type 2 diabetes mellitus and insufficient glycemic control. METHODS:Patients (initial glycated hemoglobin [HbA1c] ⩾7.5% to <11.0% [58-97mmol/mol]; main group) were randomized to: linagliptin 5mg once daily (qd); metformin 500mg twice daily (bid); metformin 1000mg bid; linagliptin 2.5mg/metformin 500mg bid; or linagliptin 2.5mg/metformin 1000mg bid. Patients with severe hyperglycemia (HbA1c ⩾11.0% [97mmol/mol]) received linagliptin 2.5mg/metformin 1000mg bid or linagliptin 5mg qd (switched at week 12 from linagliptin to SPC if HbA1c >8.0% [64mmol/mol]). The main group primary endpoint was HbA1c change from baseline to week 24. RESULTS:At week 24, adjusted mean change from baseline in HbA1c (main group, n=733) was: linagliptin 5mg qd, -1.3%; metformin 500mg bid, -1.6%; metformin 1000mg bid, -2.1%; linagliptin 2.5mg/metformin 500mg bid, -2.2%; linagliptin 2.5mg/metformin 1000mg bid, -2.3%. The first test of primary HbA1c analysis (linagliptin 2.5mg/metformin 1000mg bid vs. metformin 1000mg bid) was borderline non-significant; however, SPCs produced significantly greater reductions in HbA1c from baseline versus respective monotherapies in all but one pre-defined sensitivity analysis. In the severe hyperglycemia group (n=143), linagliptin 2.5mg/metformin 1000mg bid produced a superior HbA1c reduction (-4.7%) versus linagliptin 5mg qd (-3.5%) after 12weeks. Hypoglycemic adverse events were low across groups. CONCLUSIONS:Initial linagliptin/metformin SPC significantly improved glycemic control in this population.

journal_name

Diabetes Res Clin Pract

journal_title

Diabetes research and clinical practice

authors

Mu Y,Pan C,Fan B,Hehnke U,Zhang X,Zhang X,Wang X,Liu J,Zhang Y,Du J,Ma J,Gong Y

doi

10.1016/j.diabres.2016.11.026

subject

Has Abstract

pub_date

2017-02-01 00:00:00

pages

48-56

eissn

0168-8227

issn

1872-8227

pii

S0168-8227(16)31725-9

journal_volume

124

pub_type

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Efficacy and safety of linagliptin/metformin single-pill combination as initial therapy in drug-naïve Asian patients with type 2 diabetes.