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Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial.
Diabetes Care. 2014 Aug; 37(8):2084-90.DC

Abstract

OBJECTIVE

Insulin degludec/insulin aspart (IDegAsp) is the first combination of a basal insulin with an ultralong duration of action, and a rapid-acting insulin in a single injection. This trial compared IDegAsp with biphasic insulin aspart 30 (BIAsp 30) in adults with type 2 diabetes inadequately controlled with once- or twice-daily (OD or BID) pre- or self-mixed insulin with or without oral antidiabetic drugs.

RESEARCH DESIGN AND METHODS

In this 26-week, randomized, open-label, multinational, treat-to-target trial, participants (mean age 58.7 years, duration of diabetes 13 years, BMI 29.3 kg/m(2), and HbA1c 8.4% [68 mmol/mol]) were exposed (1:1) to BID injections of IDegAsp (n = 224) or BIAsp 30 (n = 222), administered with breakfast and the main evening meal and dose titrated to a self-measured premeal plasma glucose (PG) target of 4.0-5.0 mmol/L.

RESULTS

After 26 weeks, mean HbA1c was 7.1% (54 mmol/mol) for both groups, with IDegAsp achieving the prespecified noninferiority margin for mean change in HbA1c (estimated treatment difference [ETD] -0.03% points [95% CI -0.18 to 0.13]). Treatment with IDegAsp was superior in lowering fasting PG (ETD -1.14 mmol/L [95% CI -1.53 to -0.76], P < 0.001) and had a significantly lower final mean daily insulin dose (estimated rate ratio 0.89 [95% CI 0.83-0.96], P = 0.002). Fewer confirmed, nocturnal confirmed, and severe hypoglycemia episodes were reported for IDegAsp compared with BIAsp 30.

CONCLUSIONS

IDegAsp BID effectively improves HbA1c and fasting PG levels with fewer hypoglycemia episodes versus BIAsp 30 in patients with uncontrolled type 2 diabetes previously treated with once- or twice-daily pre- or self-mixed insulin.

Authors+Show Affiliations

University of Sydney, Royal North Shore Hospital, Australia greg.fulcher@sydney.edu.au.Aarhus University Hospital, Aarhus, Denmark.St. Johns Medical College Hospital, Bangalore, India.Bydgoszcz Diabetes and Endocrinology Center, Bydgoszcz, Poland.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.School of Medicine, University of Eastern Finland, Helsingfors, Finland.No affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24812432

Citation

Fulcher, Gregory R., et al. "Comparison of Insulin Degludec/insulin Aspart and Biphasic Insulin Aspart 30 in Uncontrolled, Insulin-treated Type 2 Diabetes: a Phase 3a, Randomized, Treat-to-target Trial." Diabetes Care, vol. 37, no. 8, 2014, pp. 2084-90.
Fulcher GR, Christiansen JS, Bantwal G, et al. Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial. Diabetes Care. 2014;37(8):2084-90.
Fulcher, G. R., Christiansen, J. S., Bantwal, G., Polaszewska-Muszynska, M., Mersebach, H., Andersen, T. H., & Niskanen, L. K. (2014). Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial. Diabetes Care, 37(8), 2084-90. https://doi.org/10.2337/dc13-2908
Fulcher GR, et al. Comparison of Insulin Degludec/insulin Aspart and Biphasic Insulin Aspart 30 in Uncontrolled, Insulin-treated Type 2 Diabetes: a Phase 3a, Randomized, Treat-to-target Trial. Diabetes Care. 2014;37(8):2084-90. PubMed PMID: 24812432.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial. AU - Fulcher,Gregory R, AU - Christiansen,Jens Sandahl, AU - Bantwal,Ganapathi, AU - Polaszewska-Muszynska,Miroslawa, AU - Mersebach,Henriette, AU - Andersen,Thomas H, AU - Niskanen,Leo K, AU - ,, Y1 - 2014/05/08/ PY - 2014/5/10/entrez PY - 2014/5/9/pubmed PY - 2015/9/15/medline SP - 2084 EP - 90 JF - Diabetes care JO - Diabetes Care VL - 37 IS - 8 N2 - OBJECTIVE: Insulin degludec/insulin aspart (IDegAsp) is the first combination of a basal insulin with an ultralong duration of action, and a rapid-acting insulin in a single injection. This trial compared IDegAsp with biphasic insulin aspart 30 (BIAsp 30) in adults with type 2 diabetes inadequately controlled with once- or twice-daily (OD or BID) pre- or self-mixed insulin with or without oral antidiabetic drugs. RESEARCH DESIGN AND METHODS: In this 26-week, randomized, open-label, multinational, treat-to-target trial, participants (mean age 58.7 years, duration of diabetes 13 years, BMI 29.3 kg/m(2), and HbA1c 8.4% [68 mmol/mol]) were exposed (1:1) to BID injections of IDegAsp (n = 224) or BIAsp 30 (n = 222), administered with breakfast and the main evening meal and dose titrated to a self-measured premeal plasma glucose (PG) target of 4.0-5.0 mmol/L. RESULTS: After 26 weeks, mean HbA1c was 7.1% (54 mmol/mol) for both groups, with IDegAsp achieving the prespecified noninferiority margin for mean change in HbA1c (estimated treatment difference [ETD] -0.03% points [95% CI -0.18 to 0.13]). Treatment with IDegAsp was superior in lowering fasting PG (ETD -1.14 mmol/L [95% CI -1.53 to -0.76], P < 0.001) and had a significantly lower final mean daily insulin dose (estimated rate ratio 0.89 [95% CI 0.83-0.96], P = 0.002). Fewer confirmed, nocturnal confirmed, and severe hypoglycemia episodes were reported for IDegAsp compared with BIAsp 30. CONCLUSIONS: IDegAsp BID effectively improves HbA1c and fasting PG levels with fewer hypoglycemia episodes versus BIAsp 30 in patients with uncontrolled type 2 diabetes previously treated with once- or twice-daily pre- or self-mixed insulin. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/24812432/Comparison_of_insulin_degludec/insulin_aspart_and_biphasic_insulin_aspart_30_in_uncontrolled_insulin_treated_type_2_diabetes:_a_phase_3a_randomized_treat_to_target_trial_ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=24812432 DB - PRIME DP - Unbound Medicine ER -