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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. [ABSTRACT FROM AUTHOR]

Aims: This study aimed to assess the effects of the hemoglobin glycation index (HGI) on hyperglycemia diagnosis and summarize the general characteristics of patients with a high-HGI phenotype.Methods: The fasting plasma glucose and glycated hemoglobin (HbA1c) levels of participants (n=47,648) were used to estimate a linear regression equation and determine the baseline HGI. Overall, 42,317 participants without a history of diabetes were included in the final analysis. The participants were divided into three groups according to the tertiles (low, moderate, and high) of baseline HGI. Proportions and variables were compared among the three HGI groups. A multivariate ordered logistic regression model was used to explore associations between related variables and the high-HGI phenotype.Results: Regression analysis indicated that the high-HGI phenotype was positively associated with female sex, advanced age, obesity, increased low-density lipoprotein and triglyceride levels, decreased high-density lipoprotein cholesterol, and postprandial glycemic excursion levels (all P<0.05). The prevalence of hyperglycemia increased from the low- to the high-HGI groups when using HbA1c for diagnosis.Conclusions: Individuals with high HGI have similar clinical characteristics. Measuring HbA1c alone for diagnosis could lead to inappropriate diabetes management decisions in people with low or high HGI. [ABSTRACT FROM AUTHOR]