Insulin degludec/insulin aspart once daily in Type 2 diabetes: a comparison of simple or stepwise titration algorithms (BOOST® : SIMPLE USE)

Diabetic Medicine : a Journal of the British Diabetic Association
S W ParkR de la Rosa

Abstract

To compare the efficacy and safety of two titration algorithms for insulin degludec/insulin aspart (IDegAsp) administered once daily with metformin in participants with insulin-naïve Type 2 diabetes mellitus. This open-label, parallel-group, 26-week, multicentre, treat-to-target trial, randomly allocated participants (1:1) to two titration arms. The Simple algorithm titrated IDegAsp twice weekly based on a single pre-breakfast self-monitored plasma glucose (SMPG) measurement. The Stepwise algorithm titrated IDegAsp once weekly based on the lowest of three consecutive pre-breakfast SMPG measurements. In both groups, IDegAsp once daily was titrated to pre-breakfast plasma glucose values of 4.0-5.0 mmol/l. Primary endpoint was change from baseline in HbA1c (%) after 26 weeks. Change in HbA1c at Week 26 was IDegAspSimple -14.6 mmol/mol (-1.3%) (to 52.4 mmol/mol; 6.9%) and IDegAspStepwise -11.9 mmol/mol (-1.1%) (to 54.7 mmol/mol; 7.2%). The estimated between-group treatment difference was -1.97 mmol/mol [95% confidence interval (CI) -4.1, 0.2] (-0.2%, 95% CI -0.4, 0.02), confirming the non-inferiority of IDegAspSimple to IDegAspStepwise (non-inferiority limit of ≤ 0.4%). Mean reduction in fasting plasma glucose and 8-point SMPG prof...Continue Reading

References

Jan 13, 2012·Journal of Managed Care Pharmacy : JMCP·Jason YeawTorsten Christensen
Jun 4, 2014·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Tim HeiseHanne Haahr

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Citations

Oct 12, 2017·Expert Opinion on Biological Therapy·Takahisa HiroseMads Peter Hemmingsen
Jul 4, 2020·Diabetes, Obesity & Metabolism·Roopa MehtaGregory Fulcher
Jan 17, 2017·Diabetic Medicine : a Journal of the British Diabetic Association·R I G Holt

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Software Mentioned

BOOST
ID
IDegAsp Stepwise
IDegAsp
IDegAsp Simple

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