Tags

Type your tag names separated by a space and hit enter

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).
Diabet Med 2017; 34(2):167-173DM

Abstract

AIMS

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.

METHODS

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).

RESULTS

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 lower with IDegAsp+IAsp than with IDet+IAsp (ratio: 0.87; 95% CI 0.79-0.95; P = 0.0026).

CONCLUSIONS

Once-daily treatment with IDegAsp and IAsp as bolus insulin for remaining meals was associated with significantly lower risk of nocturnal confirmed hypoglycaemia, improved glycaemic control and showed non-inferiority compared with IDet+IAsp, the standard of care in Type 1 diabetes.

Authors+Show Affiliations

School of Medicine, University of Washington, Seattle, WA, USA.Mossakowski Medical Research Centre, Polish Academy of Sciences and Department of Internal Diseases, Endocrinology and Diabetology, Central Clinical Hospital MSW, Warsaw, Poland.Novo Nordisk Inc., Princeton, NJ, USA.Novo Nordisk A/S, Søborg, Denmark.Aarhus University Hospital, Aarhus, Denmark.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26773446

Citation

Hirsch, I B., et al. "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, vol. 34, no. 2, 2017, pp. 167-173.
Hirsch IB, Franek E, Mersebach H, et al. 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). Diabet Med. 2017;34(2):167-173.
Hirsch, I. B., Franek, E., Mersebach, H., Bardtrum, L., & Hermansen, K. (2017). 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, 34(2), pp. 167-173. doi:10.1111/dme.13068.
Hirsch IB, et al. 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). Diabet Med. 2017;34(2):167-173. PubMed PMID: 26773446.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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). AU - Hirsch,I B, AU - Franek,E, AU - Mersebach,H, AU - Bardtrum,L, AU - Hermansen,K, Y1 - 2016/02/19/ PY - 2016/01/11/accepted PY - 2016/1/17/pubmed PY - 2018/2/14/medline PY - 2016/1/17/entrez SP - 167 EP - 173 JF - Diabetic medicine : a journal of the British Diabetic Association JO - Diabet. Med. VL - 34 IS - 2 N2 - AIMS: 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. METHODS: 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). RESULTS: 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 lower with IDegAsp+IAsp than with IDet+IAsp (ratio: 0.87; 95% CI 0.79-0.95; P = 0.0026). CONCLUSIONS: Once-daily treatment with IDegAsp and IAsp as bolus insulin for remaining meals was associated with significantly lower risk of nocturnal confirmed hypoglycaemia, improved glycaemic control and showed non-inferiority compared with IDet+IAsp, the standard of care in Type 1 diabetes. SN - 1464-5491 UR - https://www.unboundmedicine.com/medline/citation/26773446/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__ L2 - https://doi.org/10.1111/dme.13068 DB - PRIME DP - Unbound Medicine ER -