Efficacy and safety of sitagliptin as add-on therapy on glycemic control and blood glucose fluctuation in Japanese type 2 diabetes subjects ongoing with multiple daily insulin injections therapy

Abstract

To assess the efficacy and safety of adding sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, in subjects with type 2 diabetes inadequately controlled with multiple daily insulin injections therapy (MDI). HbA1c, 1,5-anhydroglucitol (1,5-AG), body mass index (BMI), insulin doses, six-point self-measured plasma glucose (SMPG) profiles were assessed before, after 12 weeks, and after 24 weeks of MDI with 50 mg/day of sitagliptin in 40 subjects with type 2 diabetes. Safety endpoints included hypoglycemia and any adverse events. HbA1c significantly decreased during the first 12 weeks ( -0.64±0.60%), and was sustained over 24 weeks ( -0.69±0.85%). 1,5-AG increased significantly from 7.5±4.5 μg/mL at baseline to 9.6±5.5 μg/mL after 24 weeks. The bolus insulin dose at 12 weeks was decreased, and the mean plasma glucose, the SD of daily glucose, M-value, and the mean amplitude of glycemic excursions (MAGE) also decreased significantly as compared with baseline values. BMI and frequency of hypoglycemia were not changed significantly. Univariate linear regression analyses revealed that % change in HbA1c was significantly associated with BMI, and % changes in the indexes of glycemic instability (SD of daily glucose and MAGE) were significantly associated with age. In conclusion, adding sitagliptin to MDI significantly improved glycemic control and decreased the daily glucose fluctuation in subjects with type 2 diabetes inadequately controlled with MDI, without weight gain or an increase in the incidence of hypoglycemia. This trial was registered with UMIN (no. UMIN000010157).

Sitagliptin Attenuates the Progression of Carotid Intima-Media Thickening in Insulin-Treated Patients With Type 2 Diabetes: The Sitagliptin Preventive Study of Intima-Media Thickness Evaluation (SPIKE)

“…Sitagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, increases insulin secretion and suppresses glucagon release by protecting the degradation of incretins without increased risk of hypoglycemia and clinically relevant weight gain (8,9). Furthermore, the addition of DPP-4 inhibitors to ongoing insulin therapy was reported to have specific advantages in reducing the frequency of hypoglycemia and weight gain, in addition to the expected benefits associated with glycemic control and limiting insulin dose (10)(11)(12).…”

Addition of sitagliptin or metformin to insulin monotherapy improves blood glucose control <i>via</i> different effects on insulin and glucagon secretion in hyperglycemic Japanese patients with type 2 diabetes

“…This meal consists of 5 crackers, a cup of pudding, and a cup of chicken cream stew and contains a total energy of 450 kcal with 51.4% from carbohydrates, 33.3% ing glucagon secretion [9][10][11][12]. Although these drugs were also demonstrated to ameliorate poor blood glucose control in insulin-treated type 2 diabetes patients [13][14][15][16], few studies have reported on blood glucose lowering mechanisms, especially in East Asian populations. In patients on insulin monotherapy, peripheral blood insulin levels are sufficient.…”

Saxagliptin is similar in glycaemic variability more effective in metabolic control than acarbose in aged type 2 diabetes inadequately controlled with metformin

“…This discrepancy may be attributed to the different subjects as well as different background treatments. For example, it is reported DPP-4 inhibitors are more efficacious in Asian [20].…”