A comparative effectiveness study of degludec and insulin glargine 300 U/mL in insulin-naïve patients with type 2 diabetes

Joseph Tibaldi, Martin Hadley-Brown, Andreas Liebl, Steffen Haldrup, Viktor Sandberg, Michael L Wolden, Helena W Rodbard, Joseph Tibaldi, Martin Hadley-Brown, Andreas Liebl, Steffen Haldrup, Viktor Sandberg, Michael L Wolden, Helena W Rodbard

Abstract

Aims: To compare the real-world effectiveness of insulin degludec (degludec) and glargine 300 units/mL (glargine U300) in insulin-naïve adult patients with type 2 diabetes in routine US clinical practice.

Materials and methods: CONFIRM is a non-interventional comparative effectiveness study following US patients across the continuum of care, through electronic medical records from multiple health systems and integrated delivery networks. Propensity-score matching controlled for confounding. The primary endpoint, change in HbA1c from baseline to 180 days of follow-up, was estimated using a repeated-measure of covariance analysis with subject as random effect. Change in the rate of hypoglycaemic episodes (defined using International Classification of Diseases codes 9/10) and change in proportion of patients with hypoglycaemia were estimated using negative binomial and logistic regression, respectively. Time-to-discontinuation of the initial basal insulin/initiation with another prescribed basal insulin was analysed using a Cox Proportional Hazard model.

Results: Data concerning 4056 patients were analysed. After matching, baseline characteristics were comparable (n = 2028 in each group). After 180 days of follow-up, degludec was associated with a larger reduction in HbA1c (estimated treatment difference, -0.27%; P = 0.03), greater reductions in change in rate (rate ratio, 0.70; P < 0.05) and greater reductions in change in the likelihood of hypoglycaemia (odds ratio, 0.64; P < 0.01]) compared with glargine U300. In addition, patients treated with degludec were 27% less likely to discontinue treatment at follow-up compared with those treated with glargine U300 (hazard ratio, 0.73; P < 0.001).

Conclusions: Significantly improved HbA1c, larger reductions in rates and likelihood of hypoglycaemia and lower risk of treatment discontinuation were demonstrated with degludec vs glargine U300.

Keywords: database research; glycaemic control; hypoglycaemia; insulin analogues; observational study; type 2 diabetes.

Conflict of interest statement

Author contributions

A. L. contributed to the analysis, writing and approval of the final manuscript. H. W. R. contributed to the study design, analysis, writing and approval of the final manuscript. M. H. B. contributed to the analysis, writing and approval of the final manuscript. J. T. contributed to the study design, analysis, writing and approval of the final manuscript. S. F. U. A., M. L. W. O. and V. T. S. A. contributed to the analysis, writing and approval of the final manuscript.

© 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Study design. Abbreviations: Glargine U300, insulin glargine 300 units/mL; T2D, type 2 diabetes
Figure 2
Figure 2
Change in HbA1C over 180 days of treatment with degludec or glargine U300. Results are presented as means with associated ETD and P value. ETD values may appear non‐arithmetic as the result of rounding of data. Robust standard errors were used to adjust for potential dependence between repeated measures on individuals. aP < 0.01 for change in HbA1c over 180 days of treatment. Abbrevations: ETD, estimated treatment difference; glargine U300, insulin glargine 300 units/mL
Figure 3
Figure 3
Change in rate of hypoglycaemic episodes and change in proportion of patients with hypoglycaemia during treatment with degludec or glargine U300. Number of patients treated represents those for whom data were available at follow‐up following propensity matching. Treatment group: degludec. Reference group: glargine U300. Abbreviations: CI, confidence interval; glargine U300, insulin glargine 300 units/mL; OR, odds ratio; RR, rate ratio
Figure 4
Figure 4
Likelihood of discontinuation of basal insulin treatment in patients who initiated treatment with degludec or glargine U300. Treatment group: glargine U300. Reference group: degludec. Abbreviations: CI, confidence interval; glargine U300, insulin glargine 300 units/mL; HR, hazard ratio

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