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Similar glycaemic control with less nocturnal hypoglycaemia in a 38-week trial comparing the IDegAsp co-formulation with insulin glargine U100 and insulin aspart in basal insulin-treated subjects with type 2 diabetes mellitus.
Diabetes Res Clin Pract. 2019 Jan; 147:157-165.DR

Abstract

AIMS

To confirm non-inferiority of insulin degludec/insulin aspart (IDegAsp) once-daily (OD) versus insulin glargine (IGlar) U100 OD + insulin aspart (IAsp) OD for HbA1c after 26 weeks, and compare efficacy and safety between groups at W26 + W38.

METHODS

A 38-week, randomised, open-label, treat-to-target (HbA1c < 7.0%) trial in adults with type 2 diabetes mellitus (on basal insulin ± oral antidiabetic drugs; HbA1c 7.0-10.0%). Randomisation (1:1): IDegAsp or IGlar U100 + IAsp. Intensification to IDegAsp twice daily (BID) was permitted at W26 + W32, or with additional IAsp injections at W26 (maximum IAsp BID) or W32 (maximum IAsp three-times daily).

RESULTS

For W0-W26, mean percentage-change (standard deviation) HbA1c was: IDegAsp, -1.1 (0.9); IGlar U100 + IAsp, -1.1 (0.8); estimated treatment difference: 0.07% (95% confidence interval [CI]: -0.06; 0.21) confirmed non-inferiority. At W26 and W38, target HbA1c achievement, and mean fasting and postprandial glucose were similar across groups. At W38, more subjects achieved target HbA1c without hypoglycaemia with IDegAsp (22.5%) than with IGlar U100 + IAsp (21.1%), with significantly fewer nocturnal episodes (W0-W38, estimated rate ratio: 0.61 [95% CI: 0.40; 0.93]). Safety profiles were similar across treatment groups throughout.

CONCLUSIONS

IDegAsp OD/BID are effective treatment intensification options versus multiple injection basal-bolus therapies, achieving similar glycaemic control, with significantly less nocturnal hypoglycaemia.

Authors+Show Affiliations

Scripps Whittier Diabetes Institute, San Diego, CA, USA. Electronic address: Philis-Tsimikas.Athena@scrippshealth.org.Saint-Petersburg Territorial Diabetic Centre, Saint-Petersburg, Russia.All India Institute of Medical Sciences, New Delhi, India.Anaheim Clinical Trials, Anaheim, CA, USA.Salah Boubnider University, Constantine, Algeria.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.Dokuz Eylül Üniversity, İzmir, Turkey.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

30448451

Citation

Philis-Tsimikas, A, et al. "Similar Glycaemic Control With Less Nocturnal Hypoglycaemia in a 38-week Trial Comparing the IDegAsp Co-formulation With Insulin Glargine U100 and Insulin Aspart in Basal Insulin-treated Subjects With Type 2 Diabetes Mellitus." Diabetes Research and Clinical Practice, vol. 147, 2019, pp. 157-165.
Philis-Tsimikas A, Astamirova K, Gupta Y, et al. Similar glycaemic control with less nocturnal hypoglycaemia in a 38-week trial comparing the IDegAsp co-formulation with insulin glargine U100 and insulin aspart in basal insulin-treated subjects with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2019;147:157-165.
Philis-Tsimikas, A., Astamirova, K., Gupta, Y., Haggag, A., Roula, D., Bak, B. A., Fita, E. G., Nielsen, A. M., & Demir, T. (2019). Similar glycaemic control with less nocturnal hypoglycaemia in a 38-week trial comparing the IDegAsp co-formulation with insulin glargine U100 and insulin aspart in basal insulin-treated subjects with type 2 diabetes mellitus. Diabetes Research and Clinical Practice, 147, 157-165. https://doi.org/10.1016/j.diabres.2018.10.024
Philis-Tsimikas A, et al. Similar Glycaemic Control With Less Nocturnal Hypoglycaemia in a 38-week Trial Comparing the IDegAsp Co-formulation With Insulin Glargine U100 and Insulin Aspart in Basal Insulin-treated Subjects With Type 2 Diabetes Mellitus. Diabetes Res Clin Pract. 2019;147:157-165. PubMed PMID: 30448451.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Similar glycaemic control with less nocturnal hypoglycaemia in a 38-week trial comparing the IDegAsp co-formulation with insulin glargine U100 and insulin aspart in basal insulin-treated subjects with type 2 diabetes mellitus. AU - Philis-Tsimikas,A, AU - Astamirova,K, AU - Gupta,Y, AU - Haggag,A, AU - Roula,D, AU - Bak,B A, AU - Fita,E G, AU - Nielsen,A M, AU - Demir,T, Y1 - 2018/11/16/ PY - 2018/07/06/received PY - 2018/10/11/revised PY - 2018/10/29/accepted PY - 2018/11/19/pubmed PY - 2019/2/13/medline PY - 2018/11/19/entrez KW - Aspart KW - Co-formulation KW - Diabetes KW - Glargine KW - Hypoglycaemia KW - IDegAsp SP - 157 EP - 165 JF - Diabetes research and clinical practice JO - Diabetes Res. Clin. Pract. VL - 147 N2 - AIMS: To confirm non-inferiority of insulin degludec/insulin aspart (IDegAsp) once-daily (OD) versus insulin glargine (IGlar) U100 OD + insulin aspart (IAsp) OD for HbA1c after 26 weeks, and compare efficacy and safety between groups at W26 + W38. METHODS: A 38-week, randomised, open-label, treat-to-target (HbA1c < 7.0%) trial in adults with type 2 diabetes mellitus (on basal insulin ± oral antidiabetic drugs; HbA1c 7.0-10.0%). Randomisation (1:1): IDegAsp or IGlar U100 + IAsp. Intensification to IDegAsp twice daily (BID) was permitted at W26 + W32, or with additional IAsp injections at W26 (maximum IAsp BID) or W32 (maximum IAsp three-times daily). RESULTS: For W0-W26, mean percentage-change (standard deviation) HbA1c was: IDegAsp, -1.1 (0.9); IGlar U100 + IAsp, -1.1 (0.8); estimated treatment difference: 0.07% (95% confidence interval [CI]: -0.06; 0.21) confirmed non-inferiority. At W26 and W38, target HbA1c achievement, and mean fasting and postprandial glucose were similar across groups. At W38, more subjects achieved target HbA1c without hypoglycaemia with IDegAsp (22.5%) than with IGlar U100 + IAsp (21.1%), with significantly fewer nocturnal episodes (W0-W38, estimated rate ratio: 0.61 [95% CI: 0.40; 0.93]). Safety profiles were similar across treatment groups throughout. CONCLUSIONS: IDegAsp OD/BID are effective treatment intensification options versus multiple injection basal-bolus therapies, achieving similar glycaemic control, with significantly less nocturnal hypoglycaemia. SN - 1872-8227 UR - https://www.unboundmedicine.com/medline/citation/30448451/Similar_glycaemic_control_with_less_nocturnal_hypoglycaemia_in_a_38_week_trial_comparing_the_IDegAsp_co_formulation_with_insulin_glargine_U100_and_insulin_aspart_in_basal_insulin_treated_subjects_with_type_2_diabetes_mellitus_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0168-8227(18)31053-2 DB - PRIME DP - Unbound Medicine ER -