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).

Russell-Jones D1, Bode BW2, De Block C3, Franek E4, Heller SR5, Mathieu C6, Philis-Tsimikas A7, Rose L8, Woo VC9, Østerskov AB10, Graungaard T10, Bergenstal RM11.

Diabetes Care. 2017 Jul;40(7):943-950. doi: 10.2337/dc16-1771. Epub 2017 Mar 29.

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).

 1   Diabetes and Endocrinology, Royal Surrey County Hospital, and University of Surrey, Guildford, U.K. Ten adres pocztowy jest chroniony przed spamowaniem. Aby go zobaczyć, konieczne jest włączenie w przeglądarce obsługi JavaScript..

2 Atlanta Diabetes Associates, Atlanta, GA.

3  Department of Endocrinology, Diabetology, and Metabolism, Antwerp University Hospital, Antwerp, Belgium.

4  Mossakowski Medical Research Center, Polish Academy of Sciences, Warsaw, Poland.

5    Department of Oncology and Metabolism, University of Sheffield, Sheffield, U.K.

6    Clinical and Experimental Endocrinology, University Hospital Leuven, Catholic University of Leuven, Leuven, Belgium.

7    Scripps Whittier Diabetes Institute, Scripps Health, San Diego, CA.

8    Institute of Diabetes Research, Münster, Germany.

9    Section of Endocrinology and Metabolism, University of Manitoba, Winnipeg, Manitoba, Canada.

10     Novo Nordisk A/S, Søborg, Denmark.

11     International Diabetes Center at Park Nicollet, Minneapolis, MN.

 

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.

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