Profil Institut für Stoffwechselforschung, Neuss, Germany.
Diabetes Care. 2010 Jul;33(7):1509-15. doi: 10.2337/dc09-2191. Epub 2010 Mar 31.
To assess the effect of a 4-week adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA) (100 mg once daily) in response to a standardized breakfast meal challenge in 48 men or women with type 2 diabetes receiving insulin glargine (GLAR) + metformin (MET).
This was a single-center, randomized, open-label, active comparator-controlled study with a three-arm parallel group design, consisting of: screening, 4- to 8-week run-in period, 4-week treatment period, and follow-up. In all three groups, the GLAR dose was titrated according to an algorithm (fasting blood glucose <or=100 mg/dl).
The unadjusted 6-h postprandial blood glucose excursion of both GLAR + MET + EXE and GLAR + MET + SITA was statistically significantly smaller than that of GLAR + MET (606 +/- 104 vs. 612 +/- 133 vs. 728 +/- 132 mg/dl/h; P = 0.0036 and 0.0008). A1C significantly decreased in all three groups (P < 0.0001), with the greatest reduction of -1.9 +/- 0.7 under GLAR + MET + EXE (GLAR + MET + SITA -1.5 +/- 0.7; GLAR + MET -1.2 +/- 0.5%-points; GLAR + MET + EXE vs. GLAR + MET P = 0.0154). The American Diabetes Association A1C target of <7.0% was reached by 80.0, 87.5, and 62.5% of subjects, respectively. GLAR + MET + EXE had the highest number (47) of adverse events, mostly gastrointestinal (56%) with one dropout. GLAR + MET or GLAR + MET + SITA only had 10 and 12 adverse events, respectively, and no dropouts. Hypoglycemia (blood glucose <50 mg/dl) rates were low and comparable among groups. Weight decreased with GLAR + MET + EXE (-0.9 +/- 1.7 kg; P = 0.0396) and increased slightly with GLAR + MET (0.4 +/- 1.5 kg; NS; GLAR + MET + EXE vs. GLAR + MET P = 0.0377).
EXE or SITA added to GLAR + MET further substantially reduced postprandial blood glucose excursions. Longer-term studies in a larger population are warranted to confirm these findings.
评估在接受甘精胰岛素（GLAR）+二甲双胍（MET）治疗的 48 例 2 型糖尿病患者中，4 周艾塞那肽（EXE）（5-10μg，bid）或西他列汀（SITA）（100mg，qd）辅助治疗对标准化早餐餐后血糖的影响。
这是一项单中心、随机、开放标签、活性对照的研究，采用三臂平行组设计，包括：筛查、4-8 周的导入期、4 周的治疗期和随访。在所有三组中，GLAR 剂量均根据算法（空腹血糖<100mg/dl）进行滴定。
GLAR+MET+EXE 和 GLAR+MET+SITA 的未经调整的 6 小时餐后血糖波动均明显小于 GLAR+MET（606±104 vs.612±133 vs.728±132mg/dl/h；P=0.0036 和 0.0008）。三组的糖化血红蛋白（HbA1c）均显著下降（P<0.0001），GLAR+MET+EXE 组降幅最大，为-1.9±0.7（GLAR+MET+SITA-1.5±0.7；GLAR+MET-1.2±0.5 个百分点；GLAR+MET+EXE 与 GLAR+MET 相比，P=0.0154）。分别有 80.0%、87.5%和 62.5%的受试者达到了美国糖尿病协会（ADA）<7.0%的 HbA1c 目标。GLAR+MET+EXE 组发生的不良事件最多（47 例），主要为胃肠道不良事件（56%），有 1 例退出。GLAR+MET 或 GLAR+MET+SITA 组分别有 10 例和 12 例不良事件，均无退出。各组低血糖（血糖<50mg/dl）发生率低且相似。体重在 GLAR+MET+EXE 组下降（-0.9±1.7kg；P=0.0396），在 GLAR+MET 组略有增加（0.4±1.5kg；NS；GLAR+MET+EXE 与 GLAR+MET 相比，P=0.0377）。
在 GLAR+MET 基础上加用 EXE 或 SITA 可进一步显著降低餐后血糖波动。需要进行更大规模的长期研究来证实这些发现。
