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Clinical Trial
. 2022 Jun;14(6):401-413.
doi: 10.1111/1753-0407.13286.

DUAL I China: Improved glycemic control with IDegLira versus its individual components in a randomized trial with Chinese participants with type 2 diabetes uncontrolled on oral antidiabetic drugs

Weiqing Wang  1 , Bue F Ross Agner  2 , Bin Luo  3 , Lei Liu  4 , Ming Liu  5 , Yongde Peng  6 , Shen Qu  7 , Karolina Amelia Stachlewska  4 , Guixia Wang  8 , Guoyue Yuan  9 , Qiu Zhang  10 , Guang Ning  1
Affiliations
Clinical Trial

DUAL I China: Improved glycemic control with IDegLira versus its individual components in a randomized trial with Chinese participants with type 2 diabetes uncontrolled on oral antidiabetic drugs

Weiqing Wang et al. J Diabetes. 2022 Jun.

Erratum in

  • Erratum.
    [No authors listed] [No authors listed] Vox Sang. 2022 Oct;117(10):1242. doi: 10.1111/vox.13360. Epub 2022 Sep 20. Vox Sang. 2022. PMID: 36125918 Free PMC article. No abstract available.
  • Corrigendum.
    [No authors listed] [No authors listed] J Diabetes. 2022 Sep;14(9):635-637. doi: 10.1111/1753-0407.13307. J Diabetes. 2022. PMID: 36163590 Free PMC article. No abstract available.

Abstract
in English, Chinese

Background: DUAL I China, one of the DUAL trials, assessed efficacy/safety of insulin degludec/liraglutide (IDegLira) in Chinese adults with type 2 diabetes (T2D) not controlled by oral antidiabetic drugs (OADs).

Methods: This phase 3a, treat-to-target multicenter trial randomized participants (glycated hemoglobin [HbA1c] 53.0-85.8 mmol/mol; previous metformin ± another OAD) 2:1:1 to IDegLira (n = 361), degludec (n = 179), or liraglutide (n = 180). Primary endpoint was change in HbA1c after 26 weeks. Secondary endpoints included: HbA1c < 53.0 mmol/mol attainment, weight change, treatment-emergent hypoglycemia, end-of-treatment insulin dose, and safety.

Results: At 26 weeks, HbA1c had decreased by a mean 18.12 mmoL/moL (IDegLira), 12.37 mmoL/moL (degludec) (estimated treatment difference [ETD] -6.50 mmoL/moL; 95% confidence interval [CI] -7.96, -5.04; P < .0001), and 11.33 mmoL/moL (liraglutide) (ETD -6.87 mmoL/moL; 95% CI -8.33, -5.41; P < 0.0001), indicating noninferiority for IDegLira vs degludec and superiority vs liraglutide. HbA1c < 53.0 mmoL/moL attainment was 77.0% (IDegLira), 46.4% (degludec), and 48.3% (liraglutide). Mean weight change with IDegLira (0.1 kg) was superior to degludec (1.2 kg) (ETD -1.08 kg; 96% CI -1.55, -0.62; P < 0.0001). Severe or confirmed hypoglycemic event rates were 0.24 (IDegLira) and 0.17 (degludec) episodes/participant-year (estimated rate ratio 1.46; 95% CI 0.71, 3.02; P = .3008, not significant). At the end of treatment, the IDegLira insulin dose was lower (24.5 U/d) vs degludec (30.3 U/d) (ETD -5.49 U; 95% CI -7.77, -3.21; P < 0.0001). No unexpected safety issues occurred.

Conclusions: IDegLira is efficacious and well tolerated in Chinese adults with T2D not controlled by OADs.

背景: 作为DUAL试验之一的DUAL I China评估了未口服抗糖药物(OADs)控制血糖的中国成人2型糖尿病(T2D)患者应用德谷胰岛素/利拉鲁肽(IDegLira)的有效性/安全性。 方法: 这项3a期, 治疗导向的多中心随机对照试验中, 受试者糖化血红蛋白(HbA1c)为53.0-85.8 mmol/mol, 之前治疗为二甲双胍配合或不配合其他口服抗糖药物。按2:1:1的比例分别给予IDegLira(n=361), 德谷胰岛素(n=179)或利拉鲁肽(n=180)。主要终点是26周后HbA1c的变化。次要终点包括:HbA1c<53.0 mmol/mol, 体重变化, 治疗后出现的低血糖, 治疗结束时的胰岛素剂量, 以及安全性。 结果: 治疗26周时, 糖化血红蛋白平均下降18.12mmol/mol(IDegLira), 12.37mmol/mol(德谷胰岛素)(治疗前后差值估计(ETD)为-6.50 mmoL/m ol, 95%可信区间−7.96, −5.04, P<0.0001)和11.33 mmoL/mol(利拉鲁肽)(ETD−6.87 mmoL/mol, 95%置信区间−8.33, −5.41, P<0.0001), 表明IDegLira相对于德谷胰岛素的非劣效性, 以及相对于利拉鲁肽的优越性。糖化血红蛋白(HbA1c)的达标率为77.0%(IDegLira), 46.4%(德谷胰岛素)和48.3%(利拉鲁肽)。平均体重变化:IDegLira组(0.1 kg)优于德谷胰岛素组(1.2 kg), ETD为-1.08 kg(95%CI−1.5 5, −0.62), P<0.001。严重或确认的低血糖事件发生率分别为0.24(IDegLira)和0.17(德谷胰岛素)次/参与者-年, 估计比率为1.46(95%CI:0.71, 3.02), P=.3008, 无显著意义。治疗结束时, IDegLira胰岛素剂量(24.5U/天)低于德谷胰岛素(30.3U/天), ETD为-5.49U[95%CI:−7.77, −3.21], P<0.0001。没有发生意外安全事件。 结论: IDegLira治疗非OADs控制的中国成人T2D是有效的且耐受性良好。.

Keywords: 2型糖尿病; Chinese; clinical trial; insulin; liraglutide; type 2 diabetes; 中国; 临床试验; 利拉鲁肽; 胰岛素.

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Figures

FIGURE 1
FIGURE 1
Trial design. AGI, alpha glucosidase inhibitor; degludec, insulin degludec; IDegLira, insulin degludec/liraglutide; OAD, oral antidiabetic drug; SU, sulphonylurea; TZD, thiazolidinedione; V, visit.
FIGURE 2
FIGURE 2
Mean (A) HbA1c,† (B) change in body weight,† (C) cumulative number of severe‐ or blood glucose‐confirmed hypoglycemic episodes per participant,‡ (D) daily insulin dose,‡ E) daily liraglutide dose,‡ (F) fasting plasma glucose,† over 26 weeks of treatment. †Full analysis set, ‡safety analysis set. For panels A, B, D, E and F, missing values were imputed using last observation carried forward. Data are mean ± standard error to the mean. For panel C, data are observed events. The week 26 mean and standard error for liraglutide dose (panel E) were recalculated after exclusion of an outlier data point, believed to be an erroneous case report form entry. Degludec, insulin degludec; FPG, fasting plasma glucose; IDegLira, insulin degludec/liraglutide; HbA1c, glycated hemoglobin; U, units.
FIGURE 3
FIGURE 3
Nine‐point SMPG profile (full analysis set) Degludec, insulin degludec; IDegLira, insulin degludec/liraglutide; SMPG, self‐measured plasma glucose.
FIGURE 4
FIGURE 4
Responder endpoints for (A) HbA1c <53.0 mmoL/moL, and (B) HbA1c ≤48.0 mmoL/moL, and composite endpoints for reaching these targets without weight gain and/or without treatment‐emergent severe or confirmed hypoglycemic episodes† (full analysis set) †Treatment‐emergent severe or BG‐confirmed hypoglycemic episodes during the final 12 weeks of treatment. Percentages are observed data. Missing values were imputed using last observation carried forward. Analysis after 26 weeks of treatment based on a logistic regression model with treatment and previous oral antidiabetic treatment as fixed factors. The covariate for: ‘Responder for HbA1c <7.0% and for HbA1c ≤6.5%’, and for ‘HbA1c responder endpoints without hypoglycemic episodes’ was baseline HbA1c; covariates for: ‘HbA1c responder endpoints without weight gain’, and for ‘HbA1c responder endpoints without hypoglycemic episodes and weight gain’ were baseline HbA1c and body weight. BG, blood glucose; CI, confidence interval; degludec, insulin degludec; IDegLira, insulin degludec/liraglutide.
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