Responses to Basal Insulin Glargine (300 U/mL and 100 U/mL) with or Without Pre-prandial Insulin in Pre-treated Subphenotypes of Type 2 Diabetes: Insights from a Post Hoc Analysis.

IF 3.8 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2024-08-01 Epub Date: 2024-06-15 DOI:10.1007/s13300-024-01608-4

Wolfgang Landgraf, David R Owens, Brian M Frier, Geremia B Bolli

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Abstract

Introduction: This study aimed to evaluate glycemic outcomes in subphenotypes of type 2 diabetes (T2D) with HbA1c > 7.0%, previously on basal insulin (pre-BI) alone (≥ 42 U/day) or on basal-bolus therapy (pre-BB), and who were switched to either basal insulin glargine 300 U/mL (IGlar-300) or 100 U/mL (IGlar-100), with or without pre-prandial insulin.

Methods: Participants from EDITION 2 (pre-BI, n = 785), and EDITION 1 (pre-BB, n = 792) trials were assigned retrospectively to subphenotypes of T2D: severe insulin deficient diabetes (SIDD), mild age-related diabetes (MARD), mild obesity diabetes (MOD), and severe insulin resistant diabetes (SIRD). Key efficacy and safety parameters were analyzed at baseline, and after 26 weeks, for IGlar-300 and IGlar-100 pooled groups according to subphenotypes. Outcomes were also compared with insulin-naïve subphenotypes on oral antihyperglycemic drugs (OADs) from the EDITION 3 trial (pre-OAD, n = 858).

Results: Pre-BI and pre-BB treated subphenotypes with SIDD had a higher mean HbA1c (8.9% and 9.1%) at baseline compared to those of MARD (7.7% and 7.8%) and MOD (8.1% and 8.2%) and after 26 weeks remained above target HbA1c (7.7% and 8.0%) despite mean glargine doses of 0.7 to 1.0 U/kg/day and pre-prandial insulin use in the pre-BB SIDD subgroup. Pre-BB treated individuals with MARD and MOD achieved lower HbA1c levels (6.9% and 7.2%) than the pre-BI groups (7.3% and 7.5%) despite similar mean FPG levels (123-130 mg/dL). Only 19-22% of participants with SIDD achieved HbA1c < 7.0% compared to 33-51% with MARD and MOD, respectively. Pre-BI and pre-BB treated subphenotypes experienced more hypoglycemia than pre-OAD treated subphenotypes.

Conclusion: Individuals with T2D assigned post hoc to the SIDD subphenotype achieved suboptimal glycemic control with glargine regimens including basal-bolus therapy, alerting clinicians to improve further diabetes treatment, particularly post-prandial glycemic control, in individuals with SIDD.

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2 型糖尿病预处理亚型患者对基础胰岛素格拉格林（300 U/mL和100 U/mL）加或不加餐前胰岛素的反应：事后分析的启示

简介该研究旨在评估 HbA1c > 7.0% 的亚型 2 型糖尿病（T2D）患者的血糖结果，这些患者之前仅使用基础胰岛素（pre-BI）（≥ 42 U/日）或基础-波隆疗法（pre-BB），后来改用格列卫基础胰岛素 300 U/mL（IGlar-300）或 100 U/mL（IGlar-100），同时使用或不使用餐前胰岛素：回顾性地将 EDITION 2（pre-BI，n = 785）和 EDITION 1（pre-BB，n = 792）试验的参与者分配到 T2D 的亚型：重度胰岛素缺乏性糖尿病（SIDD）、轻度年龄相关性糖尿病（MARD）、轻度肥胖性糖尿病（MOD）和重度胰岛素抵抗性糖尿病（SIRD）。根据亚型对IGlar-300和IGlar-100汇总组的基线和26周后的主要疗效和安全性参数进行了分析。结果还与EDITION 3试验中服用口服降糖药（OADs）的胰岛素无效亚型（OADs前，n = 858）进行了比较：与MARD（7.7%和7.8%）和MOD（8.1%和8.2%）相比，接受BI前和BB前治疗的SIDD亚型患者在基线时的平均HbA1c（8.9%和9.1%）较高，26周后仍高于目标HbA1c（7.7%和8.0%），尽管BB前SIDD亚型患者的平均格列酮剂量为0.7至1.0 U/kg/天，并使用餐前胰岛素。尽管平均 FPG 水平（123-130 mg/dL）相似，但接受胰岛素治疗前的 MARD 和 MOD 患者的 HbA1c 水平（6.9% 和 7.2%）低于接受胰岛素治疗前的患者组（7.3% 和 7.5%）。只有 19-22% 的 SIDD 参与者达到了 HbA1c 结论：临床医生应进一步改进糖尿病治疗，尤其是 SIDD 患者餐后血糖控制。

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来源期刊

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.