Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL Birmingham VA Medical Center, Birmingham, AL
Pennington Biomedical Research Center, Baton Rouge, LA.
Diabetes Care. 2014 Dec;37(12):3309-16. doi: 10.2337/dc14-0930. Epub 2014 Sep 23.
Treatment algorithms for type 2 diabetes recommend weight loss for disease management. The safety and efficacy of treatment with phentermine (PHEN)/topiramate (TPM) extended release (ER) plus lifestyle modification for weight loss and glycemic benefits were assessed in two randomized, double-blind, placebo-controlled 56-week studies of obese/overweight adults with type 2 diabetes.
The OB-202/DM-230 Study was a 56-week phase 2 trial that randomized subjects to receive once-daily placebo or PHEN/TPM ER 15 mg/92 mg (15/92). The primary end point was change in HbA₁c level. A post hoc analysis of a subpopulation with type 2 diabetes from a second study, CONQUER, is also presented. All subjects made lifestyle modifications, and comorbidities were managed to the standard of care.
The study groups comprised 130 subjects with type 2 diabetes enrolled in the OB-202/DM-230 Study (mean baseline HbA₁c 8.7% [72 mmol/mol]) and 388 subjects with type 2 diabetes in the CONQUER Study (mean baseline HbA1c 6.8% [51 mmol/mol]). At week 56 in the OB-202/DM-230, change in weight (from intent-to-treat sample with last observation carried forward [ITT-LOCF]) was -2.7% for placebo and -9.4% for PHEN/TPM ER 15/92 (P < 0.0001 vs. placebo). Change in HbA1c level (from ITT-LOCF) was -1.2% (-13.1 mmol/mol) for placebo and -1.6% (-17.5 mmol/mol) for PHEN/TPM ER 15/92 (P = 0.0381). In both the OB-202/DM-230 and CONQUER, greater numbers of patients randomized to receive PHEN/TPM ER treatment achieved HbA₁c targets with reduced need for diabetic medications when compared with the placebo group. Common adverse events included paraesthesia, constipation, and insomnia.
PHEN/TPM ER plus lifestyle modification can effectively promote weight loss and improve glycemic control as a treatment approach in obese/overweight patients with type 2 diabetes.
2 型糖尿病的治疗方案建议通过减轻体重来进行疾病管理。本研究评估了在两项为期 56 周、随机、双盲、安慰剂对照的肥胖/超重 2 型糖尿病患者临床试验中，使用盐酸苯丁胺/托吡酯控释片（PHEN/TPM）联合生活方式改变治疗对于减轻体重和改善血糖的安全性和有效性。
OB-202/DM-230 研究是一项为期 56 周的 2 期临床试验，将受试者随机分为每日一次接受安慰剂或 PHEN/TPM ER 15mg/92mg（15/92）。主要终点是糖化血红蛋白（HbA₁c）水平的变化。还对第二项研究 CONQUER 的一个亚组人群进行了事后分析。所有受试者均进行了生活方式的改变，且合并症的治疗也符合标准。
该研究包括了 130 名 2 型糖尿病患者（平均基线 HbA₁c 为 8.7%[72mmol/mol]）参加了 OB-202/DM-230 研究，388 名 2 型糖尿病患者参加了 CONQUER 研究（平均基线 HbA1c 为 6.8%[51mmol/mol]）。在 OB-202/DM-230 的第 56 周，安慰剂组体重的变化（意向治疗的最后观察结果）为-2.7%，PHEN/TPM ER 15/92 组为-9.4%（P＜0.0001 与安慰剂相比）。PHEN/TPM ER 15/92 组糖化血红蛋白水平的变化（从意向治疗的最后观察结果）为-1.2%（-13.1mmol/mol），安慰剂组为-1.6%（-17.5mmol/mol）（P=0.0381）。在 OB-202/DM-230 和 CONQUER 研究中，与安慰剂组相比，更多接受 PHEN/TPM ER 治疗的患者达到了糖化血红蛋白目标，并且减少了糖尿病药物的需求。常见的不良反应包括感觉异常、便秘和失眠。
PHEN/TPM ER 联合生活方式改变可以有效地促进肥胖/超重 2 型糖尿病患者的体重减轻和改善血糖控制，作为一种治疗方法。
