Real-World Health Outcomes of Insulin Glargine 300 U/mL vs Insulin Glargine 100 U/mL in Adults With Type 1 and Type 2 Diabetes in the Canadian LMC Diabetes Patient Registry: The REALITY Study

Abitbol, Alexander; Brown, Ruth E.; Jiandani, Dishay; Sauriol, Luc; Aronson, Ronnie

doi:10.1016/j.jcjd.2019.04.012

Cited by 15 publications

(28 citation statements)

References 13 publications

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“…Our results therefore support the current American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) consensus report for the management of hyperglycaemia in T2DM and the European summary of product characteristics for Toujeo® (IGlar U300), which state that a 10–14% [ 3 ] or 10–18% [ 8 ] higher dose of IGlar U300 versus IGlar U100 may be required to achieve similar glycaemic targets. Our results are also aligned with the results of randomised clinical trials and other real-world studies that have suggested that higher doses of IGlar U300 than IGlar U100 are needed to achieve a particular level of glycaemic control [ 11 , 18 , 24 – 26 ]. In many of these studies, as in the DosInGlar study, these patients with T2DM were insulin naïve when IGlar therapy was initiated [ 18 , 24 , 25 ].…”

Section: Discussionsupporting

confidence: 86%

Real-World Use of Insulin Glargine U100 and U300 in Insulin-Naïve Patients with Type 2 Diabetes Mellitus: DosInGlar Study

et al. 2021

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Introduction In the EDITION clinical trial programme, patients with type 2 diabetes mellitus (T2DM) receiving insulin glargine (IGlar) U300 required 10–15% more insulin than those receiving IGlar U100. This study sought to determine whether this difference was apparent in real-world practice. Methods In this observational, retrospective cohort study, electronic medical records in the Big-Pac® database (Real Life Data) relating to adult insulin-naïve patients with T2DM who initiated IGlar U100 or U300 treatment in Spain in 2016–2017 and remained on treatment for 18 months were selected. IGlar U100- and U300-treated patients were matched 1:1 (propensity score matching). The primary analysis compared changes from baseline in mean daily IGlar dose (U and U/kg) at 6 (± 2), 12 (± 2) and 18 (± 2) months between cohorts (paired t tests). Changes in glycated haemoglobin (HbA1c) and weight were analysed descriptively. Results The IGlar U100 and U300 cohorts included 556 matched pairs (46.9% female) with the following mean (standard deviation) values at baseline, respectively: age 63.6 (12.8) versus 63.7 (11.9) years; years since diagnosis 9.5 (1.4) versus 9.5 (1.3); HbA1c 8.8 (1.3) versus 8.7 (1.5) %; weight 84.6 (16.9) versus 84.7 (17.1) kg. Mean IGlar dose at baseline was 0.19 U/kg/day (both cohorts). Patients receiving IGlar U300 showed a greater increase from baseline in IGlar dose at 6, 12 and 18 months [mean dose (U/kg/day) 5.1%, 10.3% and 12.8% greater, respectively, in IGlar U300-treated patients]. Mean HbA1c was 8.1% in both cohorts at 18 months. Mean (SD) weight at 18 months with IGlar U100 and IGlar300 was 86.8 (17.0) kg and 85.0 (17.1) kg, respectively. Conclusion In real-world practice, insulin dose was significantly higher in IGlar U300-treated than U100-treated patients at 6, 12 and 18 months, with similar reductions in HbA1c. At equal IGlar price/unit in Spain, the increased dose requirements of IGlar U300 would result in higher costs. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01773-z.

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Section: Discussionsupporting

confidence: 86%

Real-World Use of Insulin Glargine U100 and U300 in Insulin-Naïve Patients with Type 2 Diabetes Mellitus: DosInGlar Study

et al. 2021

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“…Similar findings were reported in retrospective observational studies such as SPARTA in the UK [14] and REALITY in Canada [18]. In the SPARTA study, the researchers investigated 300 T1DM patients who were switched to Gla-300.…”

Section: Discussionsupporting

confidence: 64%

“…Although the mean HbA1c at baseline was >9.0% and switching was performed to achieve improved glycemic control, the increase in basal insulin dose was only 2 U/ day and the mean reduction in HbA1c levels was 0.4%. In the REALITY study, the T1DM patients switching from Gla-100, neutral protamine Hagedorn, or detemir to Gla-300 showed similarly modest HbA1c reduction (−0.17%, from 8.35% to 8.18%) with a subtle basal insulin dose change (from 0.36 U/kg to 0.38 U/kg) during follow-up [18]. On the basis of the findings of these studies, physicians and patients may be balancing the improved glycemic control against the risk of nocturnal hypoglycemia.…”

Section: Discussionmentioning

confidence: 99%

Real-world data on the use of insulin glargine 300 U/mL in Japanese patients with type 1 diabetes: twelve-month results from a post-marketing surveillance study (X-STAR study)

Matsuhisa

Odawara

Hirose

et al. 2020

Expert Opinion on Pharmacotherapy

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“…Similar randomized trials of higher-dose insulin therapy, as typical for real-world conditions, have not been conducted. Recent studies of real-world clinical settings report mean daily basal insulin doses of close to 0.60 IU/kg in the Canadian REALITY Study for insulin-experienced patients with type 2 diabetes [ 124 ] and of 0.73 IU/kg in a physician survey in New York [ 125 ]. In the European multi-centre EU-TREAT Study, mean baseline insulin doses were between 32 and 54 U per day, depending on the type of insulin therapy regimen applied [ 126 ].…”

Section: Main Textmentioning

confidence: 99%

Insulin: too much of a good thing is bad

Kolb

Kempf

Röhling

et al. 2020

BMC Med

144

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Background: Insulin shares a limited physiological concentration range with other endocrine hormones. Not only too low, but also too high systemic insulin levels are detrimental for body functions. Main body: The physiological function and clinical relevance of insulin are usually seen in association with its role in maintaining glucose homeostasis. However, insulin is an anabolic hormone which stimulates a large number of cellular responses. Not only too low, but also excess insulin concentrations are detrimental to the physiological balance. Although the glucoregulatory activity of insulin is mitigated during hyperinsulinemia by dampening the efficiency of insulin signaling ("insulin resistance"), this is not the case for most other hormonal actions of insulin, including the promotion of protein synthesis, de novo lipogenesis, and cell proliferation; the inhibition of lipolysis, of autophagy-dependent cellular turnover, and of nuclear factor E2-related factor-2 (Nrf2)-dependent antioxidative; and other defense mechanisms. Hence, there is no general insulin resistance but selective impairment of insulin signaling which causes less glucose uptake from the blood and reduced activation of endothelial NO synthase (eNOS). Because of the largely unrestricted insulin signaling, hyperinsulinemia increases the risk of obesity, type 2 diabetes, and cardiovascular disease and decreases health span and life expectancy. In epidemiological studies, high-dose insulin therapy is associated with an increased risk of cardiovascular disease. Randomized controlled trials of insulin treatment did not observe any effect on disease risk, but these trials only studied low insulin doses up to 40 IU/day. Proof for a causal link between elevated insulin levels and cardiovascular disease risk comes from Mendelian randomization studies comparing individuals with genetically controlled low or high insulin production. Conclusions: The detrimental actions of prolonged high insulin concentrations, seen also in cell culture, argue in favor of a lifestyle that limits circadian insulin levels. The health risks associated with hyperinsulinemia may have implications for treatment regimens used in type 2 diabetes.

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Real-World Health Outcomes of Insulin Glargine 300 U/mL vs Insulin Glargine 100 U/mL in Adults With Type 1 and Type 2 Diabetes in the Canadian LMC Diabetes Patient Registry: The REALITY Study

Cited by 15 publications

References 13 publications

Real-World Use of Insulin Glargine U100 and U300 in Insulin-Naïve Patients with Type 2 Diabetes Mellitus: DosInGlar Study

Real-World Use of Insulin Glargine U100 and U300 in Insulin-Naïve Patients with Type 2 Diabetes Mellitus: DosInGlar Study

Real-world data on the use of insulin glargine 300 U/mL in Japanese patients with type 1 diabetes: twelve-month results from a post-marketing surveillance study (X-STAR study)

Insulin: too much of a good thing is bad

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