The effect of basal–bolus therapy varies with baseline 1,5-anhydroglucitol level in people with Type 2 diabetes: a post hoc analysis

S. Heller, K. Bowering, Philip Raskin, A. Liebl, K. Buchholtz, A. Gorst-Rasmussen, T. R. Pieber

Research output: Contribution to journalArticle

Abstract

Aims: To investigate the impact of baseline 1,5-anhydroglucitol on the treatment effect of basal–bolus therapy in people with Type 2 diabetes. Methods: Post hoc analysis of onset 3, an 18-week, randomized, phase 3 trial evaluating the efficacy and safety of fast-acting insulin aspart in basal–bolus therapy (n = 116) vs. basal insulin-only therapy (n = 120) in people with Type 2 diabetes. The estimated treatment difference in change from baseline in HbA1c was investigated for different cut-off values of baseline 1,5-anhydroglucitol (2, 3, 4, 5 and 6 μg/ml). Results: The estimated treatment difference in change from baseline in HbA1c between basal–bolus therapy and basal insulin-only therapy was statistically significantly greater in participants with baseline 1,5-anhydroglucitol ≤3 μg/ml (n = 34) vs. >3 μg/ml (n = 198) [estimated treatment difference (95% CI): −1.53% (−2.12; −0.94) vs. −0.82% (−1.07; −0.57); P-value for interaction = 0.03]. The estimated treatment difference became more pronounced when comparing participants with 1,5-anhydroglucitol ≤2 μg/ml (n = 15) vs. >2 μg/ml (n = 217) [estimated treatment difference (95% CI): −2.26% (−3.15; −1.36) vs. −0.85% (−1.08; −0.62); P-value for interaction = 0.003]. For cut-off values ≥4 μg/ml, estimated treatment differences were numerically greater below the cut-off compared with above, although the interaction terms were not statistically significant. Conclusion: This analysis indicates that people with Type 2 diabetes with low 1,5-anhydroglucitol have an added treatment benefit with basal–bolus therapy compared with people with higher 1,5-anhydroglucitol. Further research is needed to clarify any clinical utility of these findings. Clinical Trials Registry No: NCT01850615.

Original languageEnglish (US)
Pages (from-to)1273-1278
Number of pages6
JournalDiabetic Medicine
Volume35
Issue number9
DOIs
StatePublished - Sep 1 2018

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Type 2 Diabetes Mellitus
Therapeutics
Insulin Aspart
Insulin
Registries
1,5-anhydroglucitol
Clinical Trials
Safety
Research

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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The effect of basal–bolus therapy varies with baseline 1,5-anhydroglucitol level in people with Type 2 diabetes : a post hoc analysis. / Heller, S.; Bowering, K.; Raskin, Philip; Liebl, A.; Buchholtz, K.; Gorst-Rasmussen, A.; Pieber, T. R.

In: Diabetic Medicine, Vol. 35, No. 9, 01.09.2018, p. 1273-1278.

Research output: Contribution to journalArticle

Heller, S. ; Bowering, K. ; Raskin, Philip ; Liebl, A. ; Buchholtz, K. ; Gorst-Rasmussen, A. ; Pieber, T. R. / The effect of basal–bolus therapy varies with baseline 1,5-anhydroglucitol level in people with Type 2 diabetes : a post hoc analysis. In: Diabetic Medicine. 2018 ; Vol. 35, No. 9. pp. 1273-1278.
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abstract = "Aims: To investigate the impact of baseline 1,5-anhydroglucitol on the treatment effect of basal–bolus therapy in people with Type 2 diabetes. Methods: Post hoc analysis of onset 3, an 18-week, randomized, phase 3 trial evaluating the efficacy and safety of fast-acting insulin aspart in basal–bolus therapy (n = 116) vs. basal insulin-only therapy (n = 120) in people with Type 2 diabetes. The estimated treatment difference in change from baseline in HbA1c was investigated for different cut-off values of baseline 1,5-anhydroglucitol (2, 3, 4, 5 and 6 μg/ml). Results: The estimated treatment difference in change from baseline in HbA1c between basal–bolus therapy and basal insulin-only therapy was statistically significantly greater in participants with baseline 1,5-anhydroglucitol ≤3 μg/ml (n = 34) vs. >3 μg/ml (n = 198) [estimated treatment difference (95{\%} CI): −1.53{\%} (−2.12; −0.94) vs. −0.82{\%} (−1.07; −0.57); P-value for interaction = 0.03]. The estimated treatment difference became more pronounced when comparing participants with 1,5-anhydroglucitol ≤2 μg/ml (n = 15) vs. >2 μg/ml (n = 217) [estimated treatment difference (95{\%} CI): −2.26{\%} (−3.15; −1.36) vs. −0.85{\%} (−1.08; −0.62); P-value for interaction = 0.003]. For cut-off values ≥4 μg/ml, estimated treatment differences were numerically greater below the cut-off compared with above, although the interaction terms were not statistically significant. Conclusion: This analysis indicates that people with Type 2 diabetes with low 1,5-anhydroglucitol have an added treatment benefit with basal–bolus therapy compared with people with higher 1,5-anhydroglucitol. Further research is needed to clarify any clinical utility of these findings. Clinical Trials Registry No: NCT01850615.",
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T1 - The effect of basal–bolus therapy varies with baseline 1,5-anhydroglucitol level in people with Type 2 diabetes

T2 - a post hoc analysis

AU - Heller, S.

AU - Bowering, K.

AU - Raskin, Philip

AU - Liebl, A.

AU - Buchholtz, K.

AU - Gorst-Rasmussen, A.

AU - Pieber, T. R.

PY - 2018/9/1

Y1 - 2018/9/1

N2 - Aims: To investigate the impact of baseline 1,5-anhydroglucitol on the treatment effect of basal–bolus therapy in people with Type 2 diabetes. Methods: Post hoc analysis of onset 3, an 18-week, randomized, phase 3 trial evaluating the efficacy and safety of fast-acting insulin aspart in basal–bolus therapy (n = 116) vs. basal insulin-only therapy (n = 120) in people with Type 2 diabetes. The estimated treatment difference in change from baseline in HbA1c was investigated for different cut-off values of baseline 1,5-anhydroglucitol (2, 3, 4, 5 and 6 μg/ml). Results: The estimated treatment difference in change from baseline in HbA1c between basal–bolus therapy and basal insulin-only therapy was statistically significantly greater in participants with baseline 1,5-anhydroglucitol ≤3 μg/ml (n = 34) vs. >3 μg/ml (n = 198) [estimated treatment difference (95% CI): −1.53% (−2.12; −0.94) vs. −0.82% (−1.07; −0.57); P-value for interaction = 0.03]. The estimated treatment difference became more pronounced when comparing participants with 1,5-anhydroglucitol ≤2 μg/ml (n = 15) vs. >2 μg/ml (n = 217) [estimated treatment difference (95% CI): −2.26% (−3.15; −1.36) vs. −0.85% (−1.08; −0.62); P-value for interaction = 0.003]. For cut-off values ≥4 μg/ml, estimated treatment differences were numerically greater below the cut-off compared with above, although the interaction terms were not statistically significant. Conclusion: This analysis indicates that people with Type 2 diabetes with low 1,5-anhydroglucitol have an added treatment benefit with basal–bolus therapy compared with people with higher 1,5-anhydroglucitol. Further research is needed to clarify any clinical utility of these findings. Clinical Trials Registry No: NCT01850615.

AB - Aims: To investigate the impact of baseline 1,5-anhydroglucitol on the treatment effect of basal–bolus therapy in people with Type 2 diabetes. Methods: Post hoc analysis of onset 3, an 18-week, randomized, phase 3 trial evaluating the efficacy and safety of fast-acting insulin aspart in basal–bolus therapy (n = 116) vs. basal insulin-only therapy (n = 120) in people with Type 2 diabetes. The estimated treatment difference in change from baseline in HbA1c was investigated for different cut-off values of baseline 1,5-anhydroglucitol (2, 3, 4, 5 and 6 μg/ml). Results: The estimated treatment difference in change from baseline in HbA1c between basal–bolus therapy and basal insulin-only therapy was statistically significantly greater in participants with baseline 1,5-anhydroglucitol ≤3 μg/ml (n = 34) vs. >3 μg/ml (n = 198) [estimated treatment difference (95% CI): −1.53% (−2.12; −0.94) vs. −0.82% (−1.07; −0.57); P-value for interaction = 0.03]. The estimated treatment difference became more pronounced when comparing participants with 1,5-anhydroglucitol ≤2 μg/ml (n = 15) vs. >2 μg/ml (n = 217) [estimated treatment difference (95% CI): −2.26% (−3.15; −1.36) vs. −0.85% (−1.08; −0.62); P-value for interaction = 0.003]. For cut-off values ≥4 μg/ml, estimated treatment differences were numerically greater below the cut-off compared with above, although the interaction terms were not statistically significant. Conclusion: This analysis indicates that people with Type 2 diabetes with low 1,5-anhydroglucitol have an added treatment benefit with basal–bolus therapy compared with people with higher 1,5-anhydroglucitol. Further research is needed to clarify any clinical utility of these findings. Clinical Trials Registry No: NCT01850615.

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