Safety and efficacy of insulin degludec/insulin aspart with bolus mealtime insulin aspart compared with standard basal-bolus treatment in people with Type 1 diabetes: 1-year results from a randomized clinical trial (BOOST® T1)

Diabetic Medicine : a Journal of the British Diabetic Association
Irl B HirschKjeld Hermansen

Abstract

To evaluate the long-term safety and efficacy of a simplified basal-bolus regimen of once-daily insulin degludec/insulin aspart (IDegAsp) with additional IAsp vs. a standard basal-bolus insulin regimen of insulin detemir (IDet) with IAsp in adults with Type 1 diabetes. This was an open-label trial comprising a 26-week core phase followed by a 26-week extension phase. Participants were randomized to IDegAsp once daily at the main meal and IAsp at remaining meals (IDegAsp+IAsp), or IDet (once or twice daily) and IAsp at all meals (IDet+IAsp). Insulins were titrated to target plasma glucose of < 5 mmol/l (< 90 mg/dl) at pre-breakfast (IDegAsp and IDet) and at pre-meal (IAsp). After 52 weeks, the overall confirmed hypoglycaemia rate was 31.8 episodes/patient-years of exposure (PYE) with IDegAsp+Asp and 36.7 episodes/PYE with IDet+IAsp, and the rate of nocturnal confirmed hypoglycaemia was significantly lower with IDegAsp+Asp than with IDet+IAsp (3.1 vs. 5.4 episodes/PYE, respectively; P < 0.05). Adverse event rates were comparable between groups. Mean HbA1c decreased from baseline by 0.7% (IDegAsp+IAsp) and 0.6% (IDet+IAsp), achieving 60 or 61 mmol/mol (7.6% or 7.7%, respectively), at Week 52. The mean total daily insulin dose was ...Continue Reading

References

Mar 30, 2007·Diabetes, Obesity & Metabolism·K Hermansen, M Davies
Jan 28, 2010·Diabetes Care·Mark PeyrotLuther B Travis
Jul 21, 2010·Expert Opinion on Pharmacotherapy·Michael Gejl JensenJørgen Rungby
Mar 1, 2012·Diabetes Care·Eda CengizStuart A Weinzimer
Jun 14, 2013·The Journal of Clinical Endocrinology and Metabolism·Ruth S WeinstockUNKNOWN T1D Exchange Clinic Network

❮ Previous
Next ❯

Citations

Oct 12, 2017·Expert Opinion on Biological Therapy·Takahisa HiroseMads Peter Hemmingsen
Nov 2, 2019·Current Drug Targets·Ping WuHao Fang
Aug 14, 2018·The Cochrane Database of Systematic Reviews·Ruth MartisJulie Brown
Jun 24, 2020·Current Medicine Research and Practice·Meda VenkatasubbaiahSuggala V Satyanarayana
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
Jan 7, 2020·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Andrej JanežLea Smircic-Duvnjak
Jul 8, 2016·International Journal of Clinical Practice·A KumarJ S Christiansen
May 26, 2018·Advances in Therapy·Sanjay KalraA G Unnikrishnan
Apr 22, 2017·Nature Reviews. Endocrinology·Chantal MathieuKatrien Benhalima
Mar 5, 2021·The Cochrane Database of Systematic Reviews·Bianca HemmingsenBernd Richter
Dec 2, 2021·The Journal of Clinical Endocrinology and Metabolism·Mark A JarosinskiMichael A Weiss

❮ Previous
Next ❯

Clinical Trials Mentioned

NCT00978627

Related Concepts

Related Feeds

Autoimmune Diabetes & Tolerance

Patients with type I diabetes lack insulin-producing beta cells due to the loss of immunological tolerance and autoimmune disease. Discover the latest research on targeting tolerance to prevent diabetes.