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. 2021 May;12(5):1399-1413.
doi: 10.1007/s13300-021-01046-6. Epub 2021 Mar 18.

Glycemic Variability and Time in Range During Self-titration of Once Daily Insulin Glargine 300 U/ml Versus Neutral Protamine Hagedorn Insulin in Insulin-naïve Chinese Type 2 Diabetes Patients

James Ling  1 , Emily W M Poon  1 , Aimin Yang  1   2 , Theresa Yeung  3 , Kitman Loo  3 , Risa Ozaki  3 , Ronald C W Ma  1   4 , Andrea O Y Luk  1   4 , Alice P S Kong  1   4 , Juliana C N Chan  1   2   4 , Elaine Chow  5   6
Affiliations

Glycemic Variability and Time in Range During Self-titration of Once Daily Insulin Glargine 300 U/ml Versus Neutral Protamine Hagedorn Insulin in Insulin-naïve Chinese Type 2 Diabetes Patients

James Ling et al. Diabetes Ther. 2021 May.

Abstract

Introduction: To compare glycemic variability (GV) and time in range (TIR) in Chinese patients with type 2 diabetes (T2D) initiated on once-daily bedtime insulin glargine 300U/ml (Gla-300) versus neutral protamine Hagedorn (NPH) insulin using continuous glucose monitoring (CGM).

Methods: This was a 24-week, open-label exploratory study with 1:1 randomization comparing patient-adjusted titration of Gla-300 (n = 23) versus NPH (n = 23) at bedtime in insulin-naïve T2D patients on maximum oral glucose-lowering drugs. The starting dose was 0.2 U/kg/day and with self-titration of one unit per week to achieve a target fasting glucose of 4.4-6 mmol/l, without hypoglycemia. Participants had masked CGM at baseline, weeks 11 and 24. The primary outcome was between-treatment differences in CGM glucose standard deviation (SD) at week 24.

Results: HbA1c at week 24 were similar, with 21% of Gla-300 versus 4% of NPH-treated patients achieving HbA1c < 7% without confirmed hypoglycemia. There were no differences in anytime glucose SD at week 24 (LS mean difference - 0.08 mmol/l, 95% CI [- 0.42-0.26], p = 0.63). Anytime %TIRs (3.9-10.0 mmol/l) at week 24 were similar (p = 0.91). Nocturnal % time below range < 3.9 mmol/l was significantly lower in the Gla-300 group (least squares (LS) mean difference - 5.03% [- 9.92 to - 0.14], p = 0.04) with lower % coefficient of variation (LS mean difference - 4.5% [- 8.1 to - 0.8], p = 0.018). Diurnal TIR was higher in Gla-300 patients at week 11 but there were no differences at week 24.

Conclusions: Once-daily bedtime Gla-300 was associated with lower nocturnal GV, time below range and self-reported hypoglycemia in insulin-naïve Chinese T2D patients over a 24-week study period, as compared with NPH insulin.

Clinical trial registration: ClinicalTrials.gov Identifier: NCT03389490.

Keywords: Continuous glucose monitoring; Glucose variability; Insulin analogues.

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Figures

Fig. 1
Fig. 1
Time in range during diurnal (06:00–23:59) and nocturnal periods (00:00–05:59) at baseline, weeks 11 and 24
Fig. 2
Fig. 2
Mean sensor glucose profile over 24 h in Gla-300 (turquoise) and NPH (red) groups during the study period. Data displayed are mean values pooed across patients by time of day. Data are mean 95% confidence interval
See this image and copyright information in PMC

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