The objective of this study was to evaluate the efficacy and safety of gemigliptin added to a stable dose of insulin alone or of insulin in combination with metformin in patients with type 2 diabetes mellitus. After a two‐week run‐in period, patients were randomized 2:1 to receive gemigliptin 50 mg or placebo once daily as add‐on to background therapy with insulin or insulin plus metformin for 24 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) from baseline at Week 24. Baseline characteristics were similar between the gemigliptin (n = 188) and placebo (n = 95) groups in terms of HbA1c (8.1%). At Week 24, the gemigliptin group showed a statistically significant reduction in mean HbA1c from baseline as compared with placebo (between‐group mean difference, −0.7% [95% CI, −0.9% to −0.4%]; P‐value < 0.0001). The incidence of overall adverse events and the number of hypoglycaemic adverse events were similar between the study groups. Gemigliptin added to insulin alone or to insulin in combination with metformin resulted in superior glycaemic control compared to that in the placebo group and was well tolerated for 24 weeks in patients with type 2 diabetes mellitus, without causing weight gain or increasing the incidence of hypoglycaemia.
In diabetes patients, urban lifestyle has been concerned as one of the risk factors for peripheral arterial disease (PAD). The aims of this study were to find out the prevalence and associated risk factors of PAD in type 2 diabetes patients who live in a non-urban community area. A total of 885 participants with type 2 diabetes mellitus were enrolled from six primary care units in the health network centered at Naresuan University Hospital, Phitsanulok, between May and June 2018. Ankle-brachial index (ABI) was performed in all subjects using a vascular screening device. PAD was defined by an ABI value of 0.9 or lesser at least on one leg. The predictors of PAD were analyzed using multiple logistic regression. The prevalence of PAD was 7.2% among 884 evaluable patients. Diabetic neuropathy and a history of macrovascular complications were significant predictors of PAD.
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