Journal of diabetes · 2014
Weight-neutral effect of once-daily insulin detemir in Chinese type 2 diabetes patients: subgroup analysis of the SOLVE study.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Pan Changyu, Han Ping, Ji Linong, Ji Qiuhe, Lu Juming, Lin Jing, Liu Jie, Su Benli, Shi Jingmei, Wang Penghua
Аннотация
BACKGROUND: The present subanalysis of the Study of Once Daily Levemir (SOLVE) study was to evaluate the safety and efficacy of once-daily insulin detemir as add-on to oral antidiabetic drugs (OADs) in Chinese type 2 diabetes patients according to body mass index in a real-life setting.
METHODS: In all, 3272 eligible patients who were treated with diet, exercise, and one or more OAD were prescribed once-daily insulin detemir by their physician according to routine clinical practice and were followed-up for 24 weeks. The incidence of serious adverse reactions (SADRs), including major hypoglycemia, was the primary endpoint. Subanalyses were performed on patients in the following BMI groups: normal weight (BMI < 25 kg/m2); overweight (25 ≤ BMI < 30 kg/m2); and obese (BMI ≥ 30 kg/m2).
RESULTS: No SADRs were reported during the study. Significant improvements in glycemic levels were observed in all subgroups. For normal weight, overweight, and obese patients, the mean change in HbA1c (%/[mmol/mol]) was -1.26/-14, -1.09/-12, and -1.06/-12, respectively. The mean change in fasting plasma glucose in normal weight, overweight, and obese patients was -2.77, -2.57, and -2.71 mmol/L, respectively. Slight weight gain (0.25 kg), slight weight loss (-0.36 kg), and weight loss (-1.32 kg) were observed in the normal weight, overweight, and obese patients, respectively (P < 0.001). Linear regression analysis revealed a negative relationship between weight change and baseline BMI (slope = -0.16; P < 0.001).
CONCLUSIONS: Once-daily insulin detemir as add-on to OADs in Chinese patients with type 2 diabetes showed effective glycemic control and a low risk of hypoglycemia. Weight-neutral effects were observed in different BMI subgroups.
METHODS: In all, 3272 eligible patients who were treated with diet, exercise, and one or more OAD were prescribed once-daily insulin detemir by their physician according to routine clinical practice and were followed-up for 24 weeks. The incidence of serious adverse reactions (SADRs), including major hypoglycemia, was the primary endpoint. Subanalyses were performed on patients in the following BMI groups: normal weight (BMI < 25 kg/m2); overweight (25 ≤ BMI < 30 kg/m2); and obese (BMI ≥ 30 kg/m2).
RESULTS: No SADRs were reported during the study. Significant improvements in glycemic levels were observed in all subgroups. For normal weight, overweight, and obese patients, the mean change in HbA1c (%/[mmol/mol]) was -1.26/-14, -1.09/-12, and -1.06/-12, respectively. The mean change in fasting plasma glucose in normal weight, overweight, and obese patients was -2.77, -2.57, and -2.71 mmol/L, respectively. Slight weight gain (0.25 kg), slight weight loss (-0.36 kg), and weight loss (-1.32 kg) were observed in the normal weight, overweight, and obese patients, respectively (P < 0.001). Linear regression analysis revealed a negative relationship between weight change and baseline BMI (slope = -0.16; P < 0.001).
CONCLUSIONS: Once-daily insulin detemir as add-on to OADs in Chinese patients with type 2 diabetes showed effective glycemic control and a low risk of hypoglycemia. Weight-neutral effects were observed in different BMI subgroups.
Предметные рубрики MeSH
Administration, OralAdolescentAdultAgedAged, 80 and overBlood GlucoseBody Mass IndexBody WeightChinaCohort StudiesDiabetes Mellitus, Type 2Drug Administration ScheduleFemaleFollow-Up StudiesHumansHypoglycemic AgentsInsulin DetemirInsulin, Long-ActingInternational AgenciesMaleMiddle AgedPrognosisYoung Adult