空腹血糖和餐后血糖对总体血糖控制的相对贡献：一项IV期随机试验的事后分析
Relative Contribution of Fasting and Postprandial Blood Glucose in Overall Glycemic Control: Post Hoc Analysis of a Phase IV Randomized Trial.
作者信息
Su Qing, Liu Jun, Li Pengfei, Qian Lei, Yang Wenying
机构信息
Department of Endocrinology and Metabolism, Xin Hua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Endocrinology and Metabolism, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, China.
出版信息
Diabetes Ther. 2018 Jun;9(3):987-999. doi: 10.1007/s13300-018-0403-7. Epub 2018 Mar 24.
INTRODUCTION
Few prospective clinical trials have investigated the role of fasting blood glucose (FBG) and/or postprandial glucose (PPG) in assessing overall glycemic control by using different insulin regimens. In the present post hoc analysis, we assessed the contribution of FBG and/or PPG in overall glycemic control in Chinese patients under insulin treatment.
METHODS
CLASSIFY is a phase IV, randomized, open-label, 26-week, parallel-arm, treat-to-target, multinational, controlled study in patients with type 2 diabetes mellitus to compare the efficacy and safety of insulin lispro mix 25 (LM25) and insulin lispro mix 50 (LM50) as starter insulins. Insulin was titrated with an aim to target pre-meal blood glucose (BG) levels at > 3.9 and ≤ 6.1 mmol/L before breakfast and dinner. The primary outcome assessed was the change in HbA1c from baseline.
RESULTS
Chinese patients contributed 38.7% (N = 156) of the total population. The majority of patients were male (52.6%). The mean (SD) body mass index was 24.54 (3.04) kg/m and mean (SD) HbA1c was 8.54 (1.10) % at baseline. At week 26, LM50 showed a significantly greater reduction from baseline in HbA1c (- 2.03% vs - 1.55%, P < 0.001), average daily BG (- 3.21 vs - 2.34 mmol/L, P < 0.001), average post-meal BG (- 3.58 vs - 2.39 mmol/L, P < 0.001), and average prandial BG excursion (- 1.01 vs - 0.22 mmol/L, P = 0.006) than the LM25 group. The reductions in average pre-meal BG (- 2.59 vs - 2.28 mmol/L, P = 0.137) were not significantly different between the groups. The proportion of patients achieving HbA1c targets (< 7% or ≤ 6.5%) without nocturnal hypoglycemia or weight gain was greater (P < 0.05) with LM50 compared with LM25.
CONCLUSION
LM50 achieved better overall glycemic control than LM25 as a starter insulin in Chinese patients, which may be due to greater improvement in PPG levels.
TRIAL REGISTRATION
Clinicaltrials.gov identification number: NCT01773473.
FUNDING
Eli Lilly and Company, Shanghai, China.
引言
很少有前瞻性临床试验研究空腹血糖（FBG）和/或餐后血糖（PPG）在评估使用不同胰岛素治疗方案时整体血糖控制中的作用。在本次事后分析中，我们评估了FBG和/或PPG对接受胰岛素治疗的中国患者整体血糖控制的贡献。
方法
CLASSIFY是一项IV期、随机、开放标签、为期26周的平行组、达标治疗的多国对照研究，纳入2型糖尿病患者，比较赖脯胰岛素25（LM25）和赖脯胰岛素50（LM50）作为起始胰岛素的疗效和安全性。胰岛素滴定目标是使早餐和晚餐前血糖（BG）水平>3.9且≤6.1 mmol/L。评估的主要结局是糖化血红蛋白（HbA1c）较基线的变化。
结果
中国患者占总研究人群的38.7%（N = 156）。大多数患者为男性（52.6%）。基线时，平均（标准差）体重指数为24.54（3.04）kg/m²，平均（标准差）HbA1c为8.54（1.10）%。在第26周时，与LM25组相比，LM50组HbA1c自基线的降幅更大（-2.03%对-1.55%，P<0.001），平均每日血糖（-3.21对-2.34 mmol/L，P<0.001），平均餐后血糖（-3.58对-2.39 mmol/L，P<0.001），以及平均餐时血糖波动幅度（-1.01对-0.22 mmol/L，P = 0.006）。两组间平均空腹血糖降幅（-2.59对-2.28 mmol/L，P = 0.137）无显著差异。与LM25相比，LM50组在无夜间低血糖或体重增加的情况下达到HbA1c目标（<7%或≤6.5%）的患者比例更高（P<0.05）。
结论
在中国患者中，作为起始胰岛素，LM50比LM25能实现更好的整体血糖控制，这可能是由于PPG水平改善更大。
试验注册
Clinicaltrials.gov标识符：NCT01773473。
资助
礼来公司，中国上海。
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