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Clinical Trial
. 2015 Dec;17(12):1142-9.
doi: 10.1111/dom.12532. Epub 2015 Sep 14.

Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension

H Yki-Järvinen  1   2 , R M Bergenstal  3 , G B Bolli  4 , M Ziemen  5 , M Wardecki  6 , I Muehlen-Bartmer  5 , M Maroccia  7 , M C Riddle  8
Affiliations
Clinical Trial

Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension

H Yki-Järvinen et al. Diabetes Obes Metab. 2015 Dec.

Abstract

Aims: To compare the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with insulin glargine 100 U/ml (Gla-100) over 12 months of treatment in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs (OADs).

Methods: EDITION 2 (NCT01499095) was a randomized, 6-month, multicentre, open-label, two-arm, phase IIIa study investigating once-daily Gla-300 versus Gla-100, plus OADs (excluding sulphonylureas), with a 6-month safety extension.

Results: Similar numbers of participants in each group completed 12 months of treatment [Gla-300, 315 participants (78%); Gla-100, 314 participants (77%)]. The reduction in glycated haemoglobin was maintained for 12 months with both treatments: least squares (LS) mean (standard error) change from baseline -0.55 (0.06)% for Gla-300 and -0.50 (0.06)% for Gla-100; LS mean difference -0.06 [95% confidence interval (CI) -0.22 to 0.10)%]. A significant relative reduction of 37% in the annualized rate of nocturnal confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemia was observed with Gla-300 compared with Gla-100: rate ratio 0.63 [(95% CI 0.42-0.96); p = 0.031], and fewer participants experienced ≥1 event [relative risk 0.84 (95% CI 0.71-0.99)]. Severe hypoglycaemia was infrequent. Weight gain was significantly lower with Gla-300 than Gla-100 [LS mean difference -0.7 (95% CI -1.3 to -0.2) kg; p = 0.009]. Both treatments were well tolerated with a similar pattern of adverse events (incidence of 69 and 60% in the Gla-300 and Gla-100 groups).

Conclusions: In people with type 2 diabetes treated with Gla-300 or Gla-100, and non-sulphonylurea OADs, glycaemic control was sustained over 12 months, with less nocturnal hypoglycaemia in the Gla-300 group.

Keywords: basal insulin; insulin glargine; oral antihyperglycaemic drugs; type 2 diabetes.

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Figures

Figure 1
Figure 1
Study flow. *One participant in each group received rescue therapy and withdrew from the study. The upper portion with open boxes shows participant flow during the main 6‐month study period; the lower portion with shaded boxes shows flow during the extension phase up to month 12. Gla‐100, insulin glargine 100 U/ml; Gla‐300, insulin glargine 300 U/ml; mITT, modified intention‐to‐treat.
Figure 2
Figure 2
(A) Mean daily basal insulin dose (B) glycated haemoglobin (HbA1c) ± standard error by visit (modified intention‐to‐treat population). Gla‐100, insulin glargine 100 U/ml; Gla‐300, insulin glargine 300 U/ml; s.e., standard error.
Figure 3
Figure 3
Confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemia. (A) Cumulative mean number of nocturnal (00:00–05:59 hours) events per participant. (B) Nocturnal events per participant‐year. (C) Cumulative mean number of events per participant at any time (24 h). (D) Events per participant‐year at any time (24 h; safety population). CI, confidence interval; Gla‐100, insulin glargine 100 U/ml; Gla‐300, insulin glargine 300 U/ml; RR, rate ratio.
Figure 4
Figure 4
Percentage of participants with ≥1 confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemic event during the 12‐month study on‐treatment period by time of day. Gla‐100, insulin glargine 100 U/ml; Gla‐300, insulin glargine 300 U/ml.
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References

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