Efficacy and safety of adding pioglitazone or sitagliptin to patients with type 2 diabetes insufficiently controlled with metformin and a sulfonylurea

• Main Authors: Sung-Chen Liu, 劉松臻
• Other Authors: 簡國龍
• Format: Others
• Language: en_US
• Published: 2012
• Online Access: http://ndltd.ncl.edu.tw/handle/45095085394567226888

碩士 === 國立臺灣大學 === 流行病學與預防醫學研究所 === 100 === Background: Type 2 diabetes is a progressive illness which most patients experience a progressive deterioration in glycemic control, dual combination therapy with metformin and a sulfonylurea also may not achieve or maintain glycemic control. Objective: To evaluate the efficacy and safety of add-on pioglitazone vs. sitagliptin in patients with type 2 diabetes inadequately controlled on dual therapy. Methods: This 24-week, randomized, open-label, randomized, parallel study compared pioglitazone (30 mg daily, n=59) and sitagliptin (100 mg daily, n=60) in patients with inadequate glycemic control (glycosylated hemoglobin A1c [A1C] ≥7.0% to <11.0%) while receiving a stable dose of metformin (≥1500 mg daily) and a sulfonylureas (≥half maximal dose). Results: Mean (±s.e.) change in A1C from baseline was -0.94± 0.12 % with pioglitazone and -0.71± 0.12 % with sitagliptin, for a between groups difference of -0.23±0.16 % (p=0.16). The percentages of patient achieving A1C <7% were 28.8% and 28.3% in the pioglitazone and sitagliptin groups, respectively. Mean change in fasting plasma glucose were -35.7± 4.0mg/dl with pioglitazone and -22.8± 4.0mg/dl with sitagliptin, for a between groups difference of-12.9±5.7mg/dl (p=0.02). Pioglitazone was associated with significant decrease in HOMA-IR, triglyceride, hs-CRP and increase high-density lipoprotein cholesterol, while sitagliptin did not induce changes in these parameters. Mean weight gain was higher in the pioglitazone group with a between-group difference of 1.60kg (p<0.01). Overall adverse events and the rate of hypoglycemia were similar in both groups. However, the incident of edema was higher with pioglitazone vs. sitagliptin (27% vs. 0%) and the incident of gastrointestinal adverse events was higher with sitagliptin vs. pioglitazone (20% vs.6.8%). Conclusions: Pioglitazone and sitagliptin achieved similar improvements in overall glycemic control in patients with type 2 diabetes inadequately controlled with metformin and a sulfonylurea. However there were some differences in terms of FPG, lipids, HOMA-IR, body weight change and adverse events.