Effect of Baseline Characteristics on Hypoglycaemia Risk with Insulin Glargine 100 U/mL: Post Hoc Analysis of the BEYOND 7 Study

Hailong Wan, Binhong Wen, Xueying Wang, Junfen Wang, Yunliang Zhang, Tao Ning, Binhong Duan, Yufang Li, Wei Feng, Xia Zhang, Nan Cui, Linong Ji, Hailong Wan, Binhong Wen, Xueying Wang, Junfen Wang, Yunliang Zhang, Tao Ning, Binhong Duan, Yufang Li, Wei Feng, Xia Zhang, Nan Cui, Linong Ji

Abstract

Introduction: BEYOND 7 demonstrated that a higher starting dose (0.3 U/kg) of insulin glargine 100 U/mL (Gla-100) is as safe as the standard starting dose (0.2 U/kg) in Chinese individuals with type 2 diabetes who had uncontrolled hyperglycaemia despite receiving oral antihyperglycaemic drugs. This post hoc analysis determined the effect of baseline characteristics on hypoglycaemia risk in these individuals.

Methods: Participants from BEYOND 7 were assessed based on their age at baseline (< 60 vs. ≥ 60 years), duration of diabetes (< 10 vs. ≥ 10 years), glycated haemoglobin (HbA1c; < 9 vs. ≥ 9%) and fasting plasma glucose level (FPG; < 11 vs. ≥ 11 mmol/L). Endpoints included the proportion of participants with overall confirmed (≤ 3.9 mmol/L) and symptomatic hypoglycaemia, as well as the proportion of participants who achieved an HbA1c < 7% without hypoglycaemia, the time to first achievement of fasting blood glucose (FBG) < 7 mmol/L and the change in HbA1c from baseline between the two treatment arms in each of these subgroups.

Results: The proportion of participants with overall confirmed (6.1-16.7%) or symptomatic hypoglycaemia (5.7-18.4%) or the proportion who achieved HbA1c < 7.0% without hypoglycaemia (23.6-47.4%) was similar between the two treatment arms in all subgroups, with the exception of participants with a baseline duration of diabetes ≥ 10 years who experienced more symptomatic hypoglycaemia if initiating Gla-100 at a dose of 0.3 versus 0.2 U/kg. Participants aged < 60 years with an HbA1c < 9% or ≥ 9% or a duration of diabetes of 2-10 years achieved an FBG < 7.0 mmol/L in a significantly shorter time with Gla-100 starting dose of 0.3 U/kg versus 0.2 U/kg (all p < 0.001). No significant differences were seen among the subgroups in terms of change from baseline in HbA1c.

Conclusions: Baseline age, duration of diabetes, HbA1c level and FPG level do not affect the risk of hypoglycaemia with a higher starting dose of Gla-100 versus its standard starting dose.

Trial registration: ClinicalTrials.gov: NCT02836704.

Keywords: Baseline characteristics; Hypoglycaemia; Insulin glargine; Type 2 diabetes.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Forest plots for the proportion of participants with overall confirmed hypoglycaemia (a), symptomatic hypoglycaemia (b) and a glycated haemoglobin < 7.0% without hypoglycaemia (c) by baseline characteristics subgroups in participants initiating insulin glargine 100 U/mL at a dose of 0.2 U/kg and 0.3 U/kg. The dotted vertical line represents a treatment difference of zero. Horizontal lines represent 95% confidence intervals. CI Confidence interval, ETD estimated treatment difference, FPG fasting plasma glucose, HbA1c glycated haemoglobin

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Source: PubMed

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