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Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30: a combined analysis of two Phase 3a studies in type 2 diabetes.
J Diabetes. 2016 Sep; 8(5):720-8.JD

Abstract

BACKGROUND

Insulin degludec/insulin aspart (IDegAsp) is a soluble coformulation of the basal analog insulin degludec and the rapid-acting prandial insulin aspart in a single injection. The present combined analysis of two Phase 3a trials compared the incidence of hypoglycemia in participants treated twice daily with IDegAsp or biphasic insulin aspart 30 (BIAsp 30).

METHODS

Hypoglycemia data were analyzed from two similarly designed randomized controlled open-label treat-to-target Phase 3a clinical trials of adults with type 2 diabetes (T2D). Participants were treated twice daily with IDegAsp or BIAsp 30, with breakfast and their main evening meal.

RESULTS

Over 26 weeks, the rates of overall confirmed, nocturnal confirmed and severe hypoglycemic events were 19%, 57%, and 39% lower, respectively, with IDegAsp (n = 504) than BIAsp 30 (n = 364); estimated rate ratios were 0.81 (95% confidence interval [CI] 0.67, 0.98; P = 0.0341), 0.43 (95% CI 0.31, 0.59; P = 0.0001), and 0.61 (95% CI 0.26, 1.45; P = NS). The between-treatment differences were more pronounced during the maintenance period (≥16 weeks); compared with BIAsp 30, rates of overall confirmed, nocturnal confirmed and severe hypoglycemic events with IDegAsp were 0.69 (95% CI 0.55, 0.87; -31%; P = 0.0015); 0.38 (95% CI 0.25, 0.58; -62%; P < 0.0001), and 0.16 (95% CI 0.04, 0.59; -84%; P = 0.0061), respectively.

CONCLUSIONS

Compared with BIAsp 30 twice daily, IDegAsp twice daily provided similar improvements in glycemic control with a lower risk of hypoglycemia, particularly nocturnal hypoglycemia, in subjects with T2D previously treated with insulin.

Authors+Show Affiliations

Aarhus University Hospital, Aarhus.Helsinki University Hospital and University of Helsinki, Helsinki, Finland.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.University of Sydney, Royal North Shore Hospital, Sydney, New South Wales, Australia.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26612062

Citation

Christiansen, Jens Sandahl, et al. "Lower Rates of Hypoglycemia During Maintenance Treatment With Insulin Degludec/insulin Aspart Versus Biphasic Insulin Aspart 30: a Combined Analysis of Two Phase 3a Studies in Type 2 Diabetes." Journal of Diabetes, vol. 8, no. 5, 2016, pp. 720-8.
Christiansen JS, Niskanen L, Rasmussen S, et al. Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30: a combined analysis of two Phase 3a studies in type 2 diabetes. J Diabetes. 2016;8(5):720-8.
Christiansen, J. S., Niskanen, L., Rasmussen, S., Johansen, T., & Fulcher, G. (2016). Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30: a combined analysis of two Phase 3a studies in type 2 diabetes. Journal of Diabetes, 8(5), 720-8. https://doi.org/10.1111/1753-0407.12355
Christiansen JS, et al. Lower Rates of Hypoglycemia During Maintenance Treatment With Insulin Degludec/insulin Aspart Versus Biphasic Insulin Aspart 30: a Combined Analysis of Two Phase 3a Studies in Type 2 Diabetes. J Diabetes. 2016;8(5):720-8. PubMed PMID: 26612062.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30: a combined analysis of two Phase 3a studies in type 2 diabetes. AU - Christiansen,Jens Sandahl, AU - Niskanen,Leo, AU - Rasmussen,Søren, AU - Johansen,Thue, AU - Fulcher,Greg, Y1 - 2016/03/06/ PY - 2015/07/27/received PY - 2015/10/09/revised PY - 2015/10/23/accepted PY - 2015/11/28/entrez PY - 2015/11/28/pubmed PY - 2017/4/19/medline KW - 2型糖尿病。 KW - b.i.d. treatment KW - b.i.d.治疗 KW - biphasic insulin aspart 30 KW - hypoglycemia KW - insulin degludec/insulin aspart KW - type 2 diabetes KW - 低血糖 KW - 双相门冬胰岛素30 KW - 德谷胰岛素/门冬胰岛素 SP - 720 EP - 8 JF - Journal of diabetes JO - J Diabetes VL - 8 IS - 5 N2 - BACKGROUND: Insulin degludec/insulin aspart (IDegAsp) is a soluble coformulation of the basal analog insulin degludec and the rapid-acting prandial insulin aspart in a single injection. The present combined analysis of two Phase 3a trials compared the incidence of hypoglycemia in participants treated twice daily with IDegAsp or biphasic insulin aspart 30 (BIAsp 30). METHODS: Hypoglycemia data were analyzed from two similarly designed randomized controlled open-label treat-to-target Phase 3a clinical trials of adults with type 2 diabetes (T2D). Participants were treated twice daily with IDegAsp or BIAsp 30, with breakfast and their main evening meal. RESULTS: Over 26 weeks, the rates of overall confirmed, nocturnal confirmed and severe hypoglycemic events were 19%, 57%, and 39% lower, respectively, with IDegAsp (n = 504) than BIAsp 30 (n = 364); estimated rate ratios were 0.81 (95% confidence interval [CI] 0.67, 0.98; P = 0.0341), 0.43 (95% CI 0.31, 0.59; P = 0.0001), and 0.61 (95% CI 0.26, 1.45; P = NS). The between-treatment differences were more pronounced during the maintenance period (≥16 weeks); compared with BIAsp 30, rates of overall confirmed, nocturnal confirmed and severe hypoglycemic events with IDegAsp were 0.69 (95% CI 0.55, 0.87; -31%; P = 0.0015); 0.38 (95% CI 0.25, 0.58; -62%; P < 0.0001), and 0.16 (95% CI 0.04, 0.59; -84%; P = 0.0061), respectively. CONCLUSIONS: Compared with BIAsp 30 twice daily, IDegAsp twice daily provided similar improvements in glycemic control with a lower risk of hypoglycemia, particularly nocturnal hypoglycemia, in subjects with T2D previously treated with insulin. SN - 1753-0407 UR - https://www.unboundmedicine.com/medline/citation/26612062/Lower_rates_of_hypoglycemia_during_maintenance_treatment_with_insulin_degludec/insulin_aspart_versus_biphasic_insulin_aspart_30:_a_combined_analysis_of_two_Phase_3a_studies_in_type_2_diabetes_ L2 - https://doi.org/10.1111/1753-0407.12355 DB - PRIME DP - Unbound Medicine ER -