Unmet Needs of Glycaemic Control and Risk Factors of Residual Hyperglycaemia in a Chinese Population with Type 2 Diabetes Initiating Basal Insulin: A Post Hoc Analysis of the FPG GOAL Study

Xin Wang, Guangyu Wu, Dan Shen, Xia Zhang, Wenying Yang, Xin Wang, Guangyu Wu, Dan Shen, Xia Zhang, Wenying Yang

Abstract

Introduction: To aim of this analysis was to investigate the extent and evaluate risk factors of residual hyperglycaemia in Chinese individuals with type 2 diabetes (T2D) initiating basal insulin.

Methods: FPG GOAL was a 24-week, open-label, treat-to-target randomised controlled trial in Chinese individuals with T2D inadequately controlled with oral anti-hyperglycaemic drugs initiating treatment with basal insulin. This analysis categorised participants into the following glycaemic control categories: hyperglycaemia [glycated haemoglobin (HbA1c) ≥ 53 mmol/mol (≥ 7%), fasting plasma glucose (FPG) ≥ 7.0 mmol/L], residual hyperglycaemia [HbA1c ≥ 53 mmol/mol (≥ 7%), FPG < 7.0 mmol/L], discordant [HbA1c < 53 mmol/mol (< 7%), FPG ≥ 7.0 mmol/L] and at target [HbA1c < 53 mmol/mol (< 7%), FPG < 7.0 mmol/L]. The proportion of participants in each glycaemic control category was assessed at weeks 12 and 24. Multivariable regression analyses were conducted to evaluate risk factors for residual hyperglycaemia.

Results: Of the 914 participants included, 22.1% had residual hyperglycaemia, 31.9% had hyperglycaemia, 11.1% were discordant and 29.3% were at target at week 24. More participants who were randomised to a fasting blood glucose (FBG) target of > 3.9 to ≤ 5.6 mmol/L had residual hyperglycaemia compared with participants randomised to a FBG target of > 3.9 to ≤ 6.1 mmol/L or > 3.9 to ≤ 7.0 mmol/L. Multivariable analysis indicated that higher HbA1c and lower FPG levels at baseline were associated with greater proportion of residual hyperglycaemia.

Conclusion: Some Chinese individuals with T2D may have residual hyperglycaemia 3-6 months after initiating basal insulin treatment and require further intensified treatment. Higher HbA1c and lower FPG levels could be risk factors for residual hyperglycaemia.

Trial registration: ClinicalTrials.gov identifier NCT02545842.

Keywords: China; Fasting blood glucose; Glycated haemoglobin; Insulin glargine 100 U/mL; Residual hyperglycaemia; Type 2 diabetes.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Proportion of participants by glycaemic control categories at weeks 12 and 24

References

    1. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA1c. Diabetes Care. 2003;26:881–885. doi: 10.2337/diacare.26.3.881.
    1. Riddle M, Umpierrez G, DiGenio A, Zhou R, Rosenstock J. Contributions of basal and postprandial hyperglycemia over a wide range of A1C levels before and after treatment intensification in type 2 diabetes. Diabetes Care. 2011;34:2508–2514. doi: 10.2337/dc11-0632.
    1. Wang JS, Tu S-T, Lee I-T, et al. Contribution of postprandial glucose to excess hyperglycaemia in Asian type 2 diabetic patients using continuous glucose monitoring. Diabetes Metab Res Rev. 2011;27:79–84. doi: 10.1002/dmrr.1149.
    1. Borg R, Kuenen J, Carstensen B, et al. Associations between features of glucose exposure and A1C: the A1C-Derived Average Glucose (ADAG) study. Diabetes. 2010;59:1585–1590. doi: 10.2337/db09-1774.
    1. Reznik Y, Habteab A, Castaneda J, Shin J, Joubert M. Contribution of basal and postprandial hyperglycaemia in type 2 diabetes patients treated by an intensified insulin regimen: impact of pump therapy in the OPT2mise trial. Diabetes Obes Metab. 2018;20:2435–2441. doi: 10.1111/dom.13398.
    1. American Diabetes Association. 6. Glycemic targets: standards of medical care in diabetes-2020. Diabetes Care. 2020;43:S66–S76. 10.2337/dc20-S006.
    1. International Diabetes Federation. Global guideline for type 2 diabetes. . Accessed 14 Mar 2022.
    1. Buse JB, Wexler D, Tsapas A, et al. 2019 Update to: management of hyperglycemia in type&nbsp;2 diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) Diabetes Care. 2020;43:487–493. doi: 10.2337/dci19-0066.
    1. Jia W, Weng J, Zhu D, et al. Standards of medical care for type&nbsp;2 diabetes in China 2019. Diabetes Metab Res Rev. 2019;35:e3158. doi: 10.1002/dmrr.3158.
    1. American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes—2020. Diabetes Care. 2020;43:S98–S110. 10.2337/dc20-S009.
    1. Chinese Diabetes Society Guidelines for the prevention and treatment of type 2 diabetes in China (2017 Edition) Chin J Diabetes Mellitus. 2018;10:4–67. doi: 10.3760/cma.j.issn.1674-5809.2018.01.003.
    1. Raccah D, Bretzel RG, Owens D, Riddle M. When basal insulin therapy in type 2 diabetes mellitus is not enough–what next? Diabetes Metab Res Rev. 2007;23:257–264. doi: 10.1002/dmrr.733.
    1. Monnier L, Colette C, Owens D. Postprandial and basal glucose in type 2 diabetes: assessment and respective impacts. Diabetes Technol Ther. 2011;13:S25–S32. doi: 10.1089/dia.2010.0239.
    1. Rhee EJ. Diabetes in Asians. Endocrinol Metab (Seoul) 2015;30:263–269. doi: 10.3803/EnM.2015.30.3.263.
    1. Huxley R, James WP, Barzi F, et al. Ethnic comparisons of the cross-sectional relationships between measures of body size with diabetes and hypertension. Obes Rev. 2008;9:S53–S61. doi: 10.1111/j.1467-789X.2007.00439.x.
    1. Chan JC, Malik V, Jia W, et al. Diabetes in Asia: epidemiology, risk factors, and pathophysiology. JAMA. 2009;301:2129–2140. doi: 10.1001/jama.2009.726.
    1. Ramachandran A, Snehalatha C, Shetty AS, Nanditha A. Trends in prevalence of diabetes in Asian countries. World J Diabetes. 2012;3:110–117. doi: 10.4239/wjd.v3.i6.110.
    1. Ma RC, Chan JC. Type 2 diabetes in East Asians: similarities and differences with populations in Europe and the United States. Ann N Y Acad Sci. 2013;1281:64–91. doi: 10.1111/nyas.12098.
    1. Kang X, Wang C, Lifang L, et al. Effects of different proportion of carbohydrate in breakfast on postprandial glucose excursion in normal glucose tolerance and impaired glucose regulation subjects. Diabetes Technol Ther. 2013;15:569–574. doi: 10.1089/dia.2012.0305.
    1. Atkinson FS, Foster-Powell K, Brand-Miller JC. International tables of glycemic index and glycemic load values: 2008. Diabetes Care. 2008;31:2281–2283. doi: 10.2337/dc08-1239.
    1. Livesey G, Taylor R, Livesey H, Liu S. Is there a dose-response relation of dietary glycemic load to risk of type 2 diabetes? Meta-analysis of prospective cohort studies. Am J Clin Nutr. 2013;97:584–596. doi: 10.3945/ajcn.112.041467.
    1. Dong JY, Zhang L, Zhang YH, Qin LQ. Dietary glycaemic index and glycaemic load in relation to the risk of type 2 diabetes: a meta-analysis of prospective cohort studies. Br J Nutr. 2011;106:1649–1654. doi: 10.1017/S000711451100540X.
    1. Yang W, Ma J, Yuan G, et al. Determining the optimal fasting glucose target for patients with type&nbsp;2 diabetes: results of the multicentre, open-label, randomized-controlled FPG GOAL trial. Diabetes Obes Metab. 2019;21:1973–1977. doi: 10.1111/dom.13733.
    1. Yang W, Yang Z, Zhao J, Lu H, Luo T. Assessment of three fasting plasma glucose targets for insulin glargine-based therapy in people with type 2 diabetes mellitus in China: study protocol for a randomized controlled trial. Trials. 2016;17:470. doi: 10.1186/s13063-016-1588-6.
    1. Raccah D, Chou E, Colagiuri S, et al. A global study of the unmet need for glycemic control and predictor factors among patients with type&nbsp;2 diabetes mellitus who have achieved optimal fasting plasma glucose control on basal insulin. Diabetes Metab Res Rev. 2017;33:e2858. doi: 10.1002/dmrr.2858.
    1. Ewenighi CO, Uchechukwu D, Adejumo BI, et al. Responses to glycemic control therapy according to age, gender, level of adiposity, and duration of diabetes in type&nbsp;2 diabetic patients. Indian J Med Sci. 2013;67:61–69. doi: 10.4103/0019-5359.121117.
    1. McGill JB, Vlajnic A, Knutsen PG, Recklein C, Rimler M, Fisher SJ, et al. Effect of gender on treatment outcomes in type&nbsp;2 diabetes mellitus. Diabetes Res Clin Pract. 2013;102:167–174. doi: 10.1016/j.diabres.2013.10.001.
    1. Monnier L, Colette C. Postprandial and basal hyperglycaemia in type 2 diabetes: contributions to overall glucose exposure and diabetic complications. Diabetes Metabol. 2015;41:6S9–6S15. doi: 10.1016/s1262-3636(16)30003-9.
    1. Morea N, Retnakaran R, Vidal J, et al. iGlarLixi effectively reduces residual hyperglycaemia in patients with type&nbsp;2 diabetes on basal insulin: a post hoc analysis from the LixiLan-L study. Diabetes Obes Metab. 2020;22:1683–1689. doi: 10.1111/dom.14077.
    1. Yang W, Min K, Zhou Z, et al. Efficacy and safety of lixisenatide in a predominantly Asian population with type&nbsp;2 diabetes insufficiently controlled with basal insulin: the GetGoal-L-C randomized trial. Diabetes Obes Metab. 2018;20:335–343. doi: 10.1111/dom.13072.
    1. Drucker DJ. Mechanisms of action and therapeutic application of glucagon-like peptide-1. Cell Metab. 2018;27:740–756. doi: 10.1016/j.cmet.2018.03.001.
    1. Iizuka K, Baxter M, Watanabe D, Yabe D. Benefit of insulin glargine/lixisenatide for reducing residual hyperglycaemia in Japan: post hoc analysis of the LixiLan JP-O2 trial. Diabetes Obes Metab. 2021;23:2795–2803. doi: 10.1111/dom.14537.
    1. Kaneto H, Takami A, Spranger R, Amano A, Watanabe D, Niemoeller E. Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) in Japanese patients with type&nbsp;2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs: the LixiLan JP-L randomized clinical trial. Diabetes Obes Metab. 2020;22:S3–S13. doi: 10.1111/dom.14005.
    1. Davies MJ, Russell-Jones D, Barber TM, et al. Glycaemic benefit of iGlarLixi in insulin-naive type&nbsp;2 diabetes patients with high HbA1c or those with inadequate glycaemic control on two oral antihyperglycaemic drugs in the LixiLan-O randomized trial. Diabetes Obes Metab. 2019;21:1967–1972. doi: 10.1111/dom.13791.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj