PDF(Pubmed)
Abstract：
OBJECTIVE: We evaluated whether adding basal insulin to metformin in adults with early type 2 diabetes mellitus (T2DM) would increase emotional distress relative to other treatments.
METHODS: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) of adults with T2DM of <10 years\' duration, HbA1c 6.8-8.5%, and taking metformin monotherapy randomly assigned participants to add insulin glargine U-100, sulfonylurea glimepiride, the glucagon-like peptide-1 receptor agonist liraglutide, or the dipeptidyl peptidase 4 inhibitor sitagliptin. The Emotional Distress Substudy enrolled 1,739 GRADE participants (mean [SD] age 58.0 [10.2] years, 32% female, 56% non-Hispanic White, 18% non-Hispanic Black, 17% Hispanic) and assessed diabetes distress and depressive symptoms every 6 months. Analyses examined differences at 1 year and over the 3-year follow-up.
RESULTS: Across treatments, diabetes distress (-0.24, P < 0.0001) and depressive symptoms (-0.67, P < 0.0001) decreased over 1 year. Diabetes distress was lower at 1 year for the glargine group than for the other groups combined (-0.10, P = 0.002). Diabetes distress was also lower for liraglutide than for glimepiride or sitagliptin (-0.10, P = 0.008). Over the 3-year follow-up, there were no significant group differences in total diabetes distress; interpersonal diabetes distress remained lower for those assigned to liraglutide. No significant differences were observed for depressive symptoms.
CONCLUSIONS: Contrary to expectations, this randomized trial found no evidence for a deleterious effect of basal insulin on emotional distress. Glargine lowered diabetes distress modestly at 1 year rather than increasing it. Liraglutide also reduced diabetes distress at 1 year. Results can inform treatment decisions for adults with early T2DM.
METHODS: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) of adults with T2DM of <10 years\' duration, HbA1c 6.8-8.5%, and taking metformin monotherapy randomly assigned participants to add insulin glargine U-100, sulfonylurea glimepiride, the glucagon-like peptide-1 receptor agonist liraglutide, or the dipeptidyl peptidase 4 inhibitor sitagliptin. The Emotional Distress Substudy enrolled 1,739 GRADE participants (mean [SD] age 58.0 [10.2] years, 32% female, 56% non-Hispanic White, 18% non-Hispanic Black, 17% Hispanic) and assessed diabetes distress and depressive symptoms every 6 months. Analyses examined differences at 1 year and over the 3-year follow-up.
RESULTS: Across treatments, diabetes distress (-0.24, P < 0.0001) and depressive symptoms (-0.67, P < 0.0001) decreased over 1 year. Diabetes distress was lower at 1 year for the glargine group than for the other groups combined (-0.10, P = 0.002). Diabetes distress was also lower for liraglutide than for glimepiride or sitagliptin (-0.10, P = 0.008). Over the 3-year follow-up, there were no significant group differences in total diabetes distress; interpersonal diabetes distress remained lower for those assigned to liraglutide. No significant differences were observed for depressive symptoms.
CONCLUSIONS: Contrary to expectations, this randomized trial found no evidence for a deleterious effect of basal insulin on emotional distress. Glargine lowered diabetes distress modestly at 1 year rather than increasing it. Liraglutide also reduced diabetes distress at 1 year. Results can inform treatment decisions for adults with early T2DM.
摘要：
目的：我们评估了在成人早期2型糖尿病（T2DM）患者中添加基础胰岛素是否会增加情绪困扰。
方法：降低糖尿病血糖的方法：成人T2DM病程<10年的比较有效性研究（GRADE），HbA1c6.8-8.5%，服用二甲双胍单一疗法，随机分配参与者加入甘精胰岛素U-100，磺酰脲格列美脲，胰高血糖素样肽-1受体激动剂利拉鲁肽，或二肽基肽酶4抑制剂西格列汀。情绪困扰子研究招募了1,739名年级参与者（平均年龄[SD]58.0[10.2]岁，32%女性,56%的非西班牙裔白人,18%的非西班牙裔黑人,17％西班牙裔），每6个月评估一次糖尿病困扰和抑郁症状。分析检查了1年和3年随访期间的差异。
结果：所有治疗，糖尿病困扰（-0.24，P<0.0001）和抑郁症状（-0.67，P<0.0001）在1年内减少。甘精胰岛素组1年的糖尿病困扰低于其他组(-0.10,P=0.002)。利拉鲁肽的糖尿病困扰也低于格列美脲或西格列汀（-0.10，P=0.008）。在3年的随访中，在糖尿病总困扰方面没有显著的组间差异;对于分配给利拉鲁肽的患者,人际关系糖尿病困扰仍然较低.抑郁症状没有观察到显着差异。
结论：与预期相反，这项随机试验没有发现基础胰岛素对情绪困扰有有害作用的证据.甘精胰岛素在1年时适度降低了糖尿病的困扰，而不是增加它。利拉鲁肽还可以减少1年时的糖尿病困扰。结果可以为早期T2DM成人的治疗决策提供依据。
方法：降低糖尿病血糖的方法：成人T2DM病程<10年的比较有效性研究（GRADE），HbA1c6.8-8.5%，服用二甲双胍单一疗法，随机分配参与者加入甘精胰岛素U-100，磺酰脲格列美脲，胰高血糖素样肽-1受体激动剂利拉鲁肽，或二肽基肽酶4抑制剂西格列汀。情绪困扰子研究招募了1,739名年级参与者（平均年龄[SD]58.0[10.2]岁，32%女性,56%的非西班牙裔白人,18%的非西班牙裔黑人,17％西班牙裔），每6个月评估一次糖尿病困扰和抑郁症状。分析检查了1年和3年随访期间的差异。
结果：所有治疗，糖尿病困扰（-0.24，P<0.0001）和抑郁症状（-0.67，P<0.0001）在1年内减少。甘精胰岛素组1年的糖尿病困扰低于其他组(-0.10,P=0.002)。利拉鲁肽的糖尿病困扰也低于格列美脲或西格列汀（-0.10，P=0.008）。在3年的随访中，在糖尿病总困扰方面没有显著的组间差异;对于分配给利拉鲁肽的患者,人际关系糖尿病困扰仍然较低.抑郁症状没有观察到显着差异。
结论：与预期相反，这项随机试验没有发现基础胰岛素对情绪困扰有有害作用的证据.甘精胰岛素在1年时适度降低了糖尿病的困扰，而不是增加它。利拉鲁肽还可以减少1年时的糖尿病困扰。结果可以为早期T2DM成人的治疗决策提供依据。
