Effect of Sitagliptin as Add-on Therapy in Elderly Type 2 Diabetes Patients With Inadequate Glycemic Control in Taiwan

Abstract

s u m m a r yBackground: To evaluate the effectiveness and tolerability of add-on sitagliptin in elderly Taiwanese patients with Type 2 diabetes mellitus who have inadequate glycemic control to existing oral antidiabetic agents (OADs) combination regimens. Methods: Patients were randomized to receive the existing OAD combinations or add-on with sitagliptin (100 mg daily) for 24 weeks. We measured HbA1c, fasting plasma glucose, 2-hours postprandial plasma glucose, body mass index, and recorded the hypoglycemic episodes before and after 24 weeks of adding sitagliptin 100 mg once daily to existing maximal dose of OAD combination therapy for 24 weeks. Results: Compared with the change of 0.0% (95% confidence interval: À0.6% to 0.5%) from a baseline of 10.0% in the controlled arm, HbA1c change from a mean baseline of 9.5% was À1.14% AE 1.18 after add-on sitagliptin. Confirming significant differences (p < 0.0001), sitagliptin was generally well tolerated in all study patients. The between-groups difference in body mass index was not significant after 24 weeks of treatment. Conclusion: In elderly Taiwanese patients with Type 2 diabetes mellitus with inadequate glycemic control from OAD combination, the addition of sitagliptin provided significant HbA1c lowering the efficacy over 24 weeks.

Real-World Effectiveness of Sitagliptin as Add-On Therapy in Patients With Type 2 Diabetes Mellitus

“…28 In a subgroup analysis from a randomized controlled trial that enrolled 1250 patients with DM who were not well-controlled, Reasner et al 29 concluded that the high baseline subgroup had an average HbA 1c level of 11.4%, the metformin plus sitagliptin regimen resulted in a 3.3% reduction in HbA 1c level after 18 weeks of treatment, whereas the low baseline subgroup had an average HbA 1c level of 8.4% and the metformin plus sitagliptin regimen generated a 1.5% reduction in HbA 1c level. In an open-label randomized study involving elderly patients in Taiwan, Chien et al 30 reported that 24 weeks of sitagliptin produced a reduction in the HbA 1c level of 1.3% from a baseline average HbA 1c level of 9.5% (least square mean change) compared with the control group. The effectiveness of sitagliptin in patients with a high HbA 1c level at baseline consistently resulted in better HbA 1c level reduction than in the patients with a low HbA 1c level at baseline.…”

Diabetes in Older People

“…DPP-4 inhibitors (alogliptin, linagliptin, saxagliptin and sitagliptin) are similarly effective and safe in young and older people with diabetes, cause minimal hypoglycemia when used alone (or with metformin) and do not result in weight gain (123)(124)(125)(126)(127)(128)(129)(130)(131)(132). Large numbers of older people have been enrolled in studies of these drugs, including those over 75 and with multiple comorbidities.…”

Risk of diarrhea in patients with type 2 diabetes mellitus treated with sitagliptin: a meta-analysis of 30 randomized clinical trials

“… 20 No events of diarrhea were reported in the two trials. 39 , 40 Based on data from 5,362 patients, the overall incidence of diarrhea was 4.48% (95% CI: 3.59%–5.58%; Figure 2 ) according to the random-effects model.…”