Effect of 52-week liraglutide treatment on diabetes risk and glycaemic control in women with obesity and prior gestational diabetes. A randomized, double-blind, placebo-controlled study

Q2 Medicine
Roosa Perämäki , Meri-Maija Ollila , Janne Hukkanen , Marja Vääräsmäki , Jukka Uotila , Saara Metso , Heidi Hakkarainen , Reeta Rintamäki , Eliisa Löyttyniemi , Heidi Immonen , Risto Kaaja
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引用次数: 0

Abstract

Aims

We investigated the effect of 52-week liraglutide treatment on the incidence of type 2 diabetes (T2D) compared with placebo treatment in women with obesity and previous gestational diabetes (pGDM) requiring medical treatment. As secondary outcomes, the prevalence of prediabetes and glycaemic control were investigated.

Methods

Women were randomized to once daily subcutaneous liraglutide 1.8 mg or placebo for 52 weeks. Oral glucose tolerance test, C-peptide, insulin, HbA1c and lipids were determined at baseline, 26 weeks, and 52 weeks.

Results

In total, 75 women [mean age of 34.5 years, median BMI of 38.0 kg/m2] were assigned to liraglutide (n = 37) or placebo (n = 38). At 52 weeks, T2D was diagnosed in 3% (n = 1) of the liraglutide group and 8% (n = 2) of the placebo group (p = 0.58), and prediabetes in 27% (n = 9) and 58% (n = 15), respectively (p = 0.032). In intention-to-treat analysis, 52-week liraglutide treatment reduced fasting glucose [group × time interaction p = 0.0047; estimated treatment difference (ETD) at 52 weeks −0.5 mmol/L, p = 0.0020], HbA1c [p = 0.020; ETD -0.2% (−2.1 mmol/mol), p = 0.056], weight (p = 0.0087; ETD -6.2 kg, p = 0.20) and waist circumference (p = 0.022; ETD -3.9 cm, p = 0.25), and improved Matsuda index (p = 0.049; ETD 0.7, p = 0.011) compared with placebo.

Conclusions

Liraglutide reduces the prevalence of prediabetes and improves glycaemic control in women with obesity and pGDM. Due to few T2D cases, the effect of liraglutide on diabetes risk could not be reliably assessed.
利拉鲁肽治疗52周对肥胖合并妊娠糖尿病妇女糖尿病风险及血糖控制的影响。一项随机、双盲、安慰剂对照的研究
目的:研究利拉鲁肽治疗52周后,与安慰剂治疗相比,对需要药物治疗的肥胖和既往妊娠期糖尿病(pGDM)妇女2型糖尿病(T2D)发病率的影响。作为次要结局,研究了前驱糖尿病的患病率和血糖控制。方法随机选择每日1次皮下注射利拉鲁肽1.8 mg组或安慰剂组,连续52周。分别在基线、26周和52周检测口服糖耐量、c肽、胰岛素、糖化血红蛋白和血脂。结果共有75名女性[平均年龄34.5岁,中位BMI为38.0 kg/m2]被分配到利拉鲁肽组(n = 37)或安慰剂组(n = 38)。52周时,利拉鲁肽组中有3% (n = 1)和8% (n = 2)的患者被诊断为T2D (p = 0.58),而前驱糖尿病患者分别为27% (n = 9)和58% (n = 15) (p = 0.032)。意向治疗分析中,52周利拉鲁肽治疗可降低空腹血糖[组×时间相互作用p = 0.0047;估计治疗差异(ETD)在52周- 0.5 mmol/L, p = 0.0020), HbA1c [p = 0.020;要领(−2.1更易与摩尔)-0.2%,p = 0.056),体重(p = 0.0087;ETD -6.2 kg, p = 0.20)和腰围(p = 0.022;ETD -3.9 cm, p = 0.25),改善了Matsuda指数(p = 0.049;ETD为0.7,p = 0.011)。结论利拉鲁肽可降低糖尿病前期患者的患病率,改善肥胖和重度糖尿病女性的血糖控制。由于T2D病例较少,利拉鲁肽对糖尿病风险的影响不能可靠地评估。
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来源期刊
Obesity Medicine
Obesity Medicine Medicine-Public Health, Environmental and Occupational Health
CiteScore
5.50
自引率
0.00%
发文量
74
审稿时长
40 days
期刊介绍: The official journal of the Shanghai Diabetes Institute Obesity is a disease of increasing global prevalence with serious effects on both the individual and society. Obesity Medicine focusses on health and disease, relating to the very broad spectrum of research in and impacting on humans. It is an interdisciplinary journal that addresses mechanisms of disease, epidemiology and co-morbidities. Obesity Medicine encompasses medical, societal, socioeconomic as well as preventive aspects of obesity and is aimed at researchers, practitioners and educators alike.
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