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Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1).
Diabetes Care 2017; 40(7):943-950DC

Abstract

OBJECTIVE

This multicenter, treat-to-target, phase 3 trial evaluated the efficacy and safety of fast-acting insulin aspart (faster aspart) versus conventional insulin aspart (IAsp) in adults with type 1 diabetes.

RESEARCH DESIGN AND METHODS

The primary end point was change from baseline in HbA1c after 26 weeks. After an 8-week run-in, subjects were randomized (1:1:1) to double-blind mealtime faster aspart (n = 381), IAsp (n = 380), or open-label postmeal faster aspart (n = 382)-each with insulin detemir.

RESULTS

HbA1c was reduced in both treatment groups, and noninferiority to IAsp was confirmed for both mealtime and postmeal faster aspart (estimated treatment difference [ETD] faster aspart-IAsp, mealtime, -0.15% [95% CI -0.23; -0.07], and postmeal, 0.04% [-0.04; 0.12]); mealtime faster aspart statistically significantly reduced HbA1c versus IAsp (P = 0.0003). Postprandial plasma glucose (PPG) increments were statistically significantly lower with mealtime faster aspart at 1 h (ETD -1.18 mmol/L [95% CI -1.65; -0.71], -21.21 mg/dL [-29.65; -12.77]; P < 0.0001) and 2 h (-0.67 mmol/L [-1.29; -0.04], -12.01 mg/dL [-23.33; -0.70]; P = 0.0375) after the meal test; superiority to IAsp for the 2-h PPG increment was confirmed. The overall rate of severe or blood glucose-confirmed (plasma glucose <3.1 mmol/L [56 mg/dL]) hypoglycemic episodes and safety profiles were similar between treatments.

CONCLUSIONS

Faster aspart effectively improved HbA1c, and noninferiority to IAsp was confirmed, with superior PPG control for mealtime faster aspart versus IAsp. Subjects randomized to postmeal faster aspart for all meals maintained HbA1c noninferior to that obtained with mealtime IAsp.

Authors+Show Affiliations

Diabetes and Endocrinology, Royal Surrey County Hospital, and University of Surrey, Guildford, U.K. davidrussell-jones@nhs.net.Atlanta Diabetes Associates, Atlanta, GA.Department of Endocrinology, Diabetology, and Metabolism, Antwerp University Hospital, Antwerp, Belgium.Mossakowski Medical Research Center, Polish Academy of Sciences, Warsaw, Poland.Department of Oncology and Metabolism, University of Sheffield, Sheffield, U.K.Clinical and Experimental Endocrinology, University Hospital Leuven, Catholic University of Leuven, Leuven, Belgium.Scripps Whittier Diabetes Institute, Scripps Health, San Diego, CA.Institute of Diabetes Research, Münster, Germany.Section of Endocrinology and Metabolism, University of Manitoba, Winnipeg, Manitoba, Canada.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.International Diabetes Center at Park Nicollet, Minneapolis, MN.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28356319

Citation

Russell-Jones, David, et al. "Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1)." Diabetes Care, vol. 40, no. 7, 2017, pp. 943-950.
Russell-Jones D, Bode BW, De Block C, et al. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1). Diabetes Care. 2017;40(7):943-950.
Russell-Jones, D., Bode, B. W., De Block, C., Franek, E., Heller, S. R., Mathieu, C., ... Bergenstal, R. M. (2017). Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1). Diabetes Care, 40(7), pp. 943-950. doi:10.2337/dc16-1771.
Russell-Jones D, et al. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1). Diabetes Care. 2017;40(7):943-950. PubMed PMID: 28356319.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1). AU - Russell-Jones,David, AU - Bode,Bruce W, AU - De Block,Christophe, AU - Franek,Edward, AU - Heller,Simon R, AU - Mathieu,Chantal, AU - Philis-Tsimikas,Athena, AU - Rose,Ludger, AU - Woo,Vincent C, AU - Østerskov,Anne Birk, AU - Graungaard,Tina, AU - Bergenstal,Richard M, Y1 - 2017/03/29/ PY - 2016/08/16/received PY - 2017/02/27/accepted PY - 2017/3/31/pubmed PY - 2017/12/29/medline PY - 2017/3/31/entrez SP - 943 EP - 950 JF - Diabetes care JO - Diabetes Care VL - 40 IS - 7 N2 - OBJECTIVE: This multicenter, treat-to-target, phase 3 trial evaluated the efficacy and safety of fast-acting insulin aspart (faster aspart) versus conventional insulin aspart (IAsp) in adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: The primary end point was change from baseline in HbA1c after 26 weeks. After an 8-week run-in, subjects were randomized (1:1:1) to double-blind mealtime faster aspart (n = 381), IAsp (n = 380), or open-label postmeal faster aspart (n = 382)-each with insulin detemir. RESULTS: HbA1c was reduced in both treatment groups, and noninferiority to IAsp was confirmed for both mealtime and postmeal faster aspart (estimated treatment difference [ETD] faster aspart-IAsp, mealtime, -0.15% [95% CI -0.23; -0.07], and postmeal, 0.04% [-0.04; 0.12]); mealtime faster aspart statistically significantly reduced HbA1c versus IAsp (P = 0.0003). Postprandial plasma glucose (PPG) increments were statistically significantly lower with mealtime faster aspart at 1 h (ETD -1.18 mmol/L [95% CI -1.65; -0.71], -21.21 mg/dL [-29.65; -12.77]; P < 0.0001) and 2 h (-0.67 mmol/L [-1.29; -0.04], -12.01 mg/dL [-23.33; -0.70]; P = 0.0375) after the meal test; superiority to IAsp for the 2-h PPG increment was confirmed. The overall rate of severe or blood glucose-confirmed (plasma glucose <3.1 mmol/L [56 mg/dL]) hypoglycemic episodes and safety profiles were similar between treatments. CONCLUSIONS: Faster aspart effectively improved HbA1c, and noninferiority to IAsp was confirmed, with superior PPG control for mealtime faster aspart versus IAsp. Subjects randomized to postmeal faster aspart for all meals maintained HbA1c noninferior to that obtained with mealtime IAsp. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/28356319/Fast_Acting_Insulin_Aspart_Improves_Glycemic_Control_in_Basal_Bolus_Treatment_for_Type_1_Diabetes:_Results_of_a_26_Week_Multicenter_Active_Controlled_Treat_to_Target_Randomized_Parallel_Group_Trial__onset_1__ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=28356319 DB - PRIME DP - Unbound Medicine ER -