Real-world evidence of the effectiveness on glycaemic control of early simultaneous versus later sequential initiation of basal insulin and glucagon-like peptide-1 receptor agonists - PubMed (original) (raw)

. 2020 Dec;22(12):2295-2304.

doi: 10.1111/dom.14154. Epub 2020 Sep 2.

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Real-world evidence of the effectiveness on glycaemic control of early simultaneous versus later sequential initiation of basal insulin and glucagon-like peptide-1 receptor agonists

Julio Rosenstock et al. Diabetes Obes Metab. 2020 Dec.

Abstract

Aim: To assess the impact of the timing of initiating both basal insulin and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) on reaching glycaemic control targets over 6 and 12 months in people with type 2 diabetes (T2D) uncontrolled on oral antihyperglycaemic drugs with an HbA1c of 9% or higher.

Methods: This retrospective cohort study assessed the impact of the timing of initiating both basal insulin and GLP-1 RA therapies on reaching glycaemic targets (HbA1c < 7% and <8%, and ≥1% and ≥2% HbA1c reduction) over 12 months in people with markedly uncontrolled T2D (HbA1c ≥ 9%) on oral antihyperglycaemic drugs identified on the Optum Humedica database (electronic medical records; 1 January 2011 to 30 June 2017). Study cohorts were defined by the days between initiating each injectable: cohort A, 30 days or less (simultaneous initiation) and cohorts B, 31-90, C, 91-180, D, 181-270 and E, 271-360 days (sequential initiation).

Results: Cohort A had the best glycaemic outcomes at 6 and 12 months for all four endpoints, followed by cohort B. The likelihood of achieving an HbA1c of less than 7% did not significantly differ between cohorts A and B (hazard ratio [95% confidence interval]: 0.87 [0.76-1.01]); cohorts C, D and E were significantly less likely to achieve an HbA1c of less than 7% than cohort A (0.62 [0.53-0.72]; 0.62 [0.53-0.72]; 0.63 [0.54-0.73]).

Conclusions: In people with uncontrolled T2D requiring treatment with a GLP-1 RA and basal insulin, greater improvements in glycaemic control were observed when both therapies were initiated within close proximity of one another (≤90 days) compared with initiation 91-360 days apart.

Keywords: GLP-1 analogue; basal insulin; cohort study; database research; glycaemic control; type 2 diabetes.

© 2020 John Wiley & Sons Ltd.

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Conflict of interest statement

JR has served on advisory panels for Applied Therapeutics, Boehringer Ingelheim, Eli Lilly, Intarcia, Janssen, Lexicon, Novo Nordisk, Oramed and Sanofi; and has received research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genentech, GlaxoSmithKline, Intarcia, Janssen, Lexicon, Merck, Novo Nordisk, Oramed, Pfizer and Sanofi. FJAB has served on advisory panels for Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, LifeScan, Medtronic, Merck, Novartis, Novo Nordisk, Pfizer, Roche and Sanofi; and has received research support from Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, LifeScan Merck, Novo Nordisk, Pfizer, Sanofi and Servier. RL and AB are employees of Sanofi. XVP was employed by Sanofi at the time the study was conducted. LS has received research grants from Chiasma, Genentech and Sanofi; and has stock options with BRAVO4Health. VF has received research grants from Bayer, Boehringer Ingelheim and Gilead; has received honoraria for consulting and lectures from Abbott, Asahi, AstraZeneca, Eli, Intarcia, Novo Nordisk and Takeda; has stock options with BRAVO4Health, Insulin Algorithms and Microbiome Technologies; and has stock in Amgen.

Figures

FIGURE 1

FIGURE 1

Proportion of participants reaching A, HbA1c < 7.0%, B, HbA1c < 8.0%, C, ≥1% reduction in HbA1c from baseline and D, ≥2% reduction in HbA1c from baseline at 6 and 12 months in each cohort. Proportion calculated as number of patients with outcome over the number of patients with ≥1 HbA1c value. CI, confidence interval

FIGURE 2

FIGURE 2

Characteristics affecting glycaemic control (HbA1c < 7.0%) achievement. Associations calculated by multivariate cox regression model. BI, basal insulin; CCI, Charlson co‐morbidity index; CI, confidence interval; GLP‐1 RA, glucagon‐like peptide‐1 receptor agonist; HR, hazard ratio; MI, myocardial infarction; NPH, neutral protamine Hagedorn

FIGURE 3

FIGURE 3

Change in A, HbA1c, and B, weight from baseline to months 6 and 12 by cohort. ΔHbA1c is mean change from baseline to month 6 or 12. Δweight is mean change from baseline to month 6 or 12. Baseline weight data include every participant with a baseline weight value. Change from baseline weight data include every participant with a baseline and a month 6 or month 12 weight value, as appropriate

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