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Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial.
Diabetes Care 2017; 40(7):951-957DC

Abstract

OBJECTIVE

This multicenter, double-blind, treat-to-target, phase 3 trial evaluated the efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp) in adults with type 2 diabetes receiving basal insulin and oral antidiabetic agents. RESEARCH DESIGN AND METHODS: The primary end point was HbA1c change from baseline after 26 weeks' treatment. After an 8-week run-in to optimize basal insulin, subjects were randomized (1:1) to mealtime faster aspart (n = 345) or IAsp (n = 344), titrated using a simple daily patient-driven algorithm, plus insulin glargine U100 and metformin.

RESULTS

HbA1c change was -1.38% (faster aspart) and -1.36% (IAsp); mean HbA1c was 6.6% for both groups. Faster aspart demonstrated noninferiority versus IAsp in reducing HbA1c (estimated treatment difference [ETD] [95% CI] -0.02% [-0.15; 0.10]). Both treatments improved postprandial plasma glucose (PPG) control; the PPG increment (liquid meal test) was statistically significant in favor of faster aspart after 1 h (ETD [95% CI] -0.59 mmol/L [-1.09; -0.09]; -10.63 mg/dL [-19.56; -1.69]; P = 0.0198), but not after 2-4 h. Change from baseline in fasting plasma glucose, body weight, and overall severe/blood glucose-confirmed hypoglycemia rates (rate ratio [RR] [95% CI] 1.09 [0.88; 1.36]) were similar between treatments. Postmeal hypoglycemia (0-2 h) rates were 2.27 (faster aspart) and 1.49 (IAsp) per patient-year of exposure (RR [95% CI] 1.60 [1.13; 2.27]).

CONCLUSIONS

Faster aspart and IAsp were confirmed noninferior in a basal-bolus regimen regarding change from baseline in HbA1c. Faster aspart improved 1-h PPG with no differences in 2-4-h PPG versus IAsp. Overall hypoglycemia rates were similar except for an increase in 0-2-h postmeal hypoglycemia with faster aspart.

Authors+Show Affiliations

Division of Endocrinology and Metabolism, University of Alberta, Edmonton, Alberta, Canada keith.bowering@ualberta.ca.Jefferson City Medical Group, Jefferson City, MO.Gladstone Centre, Maelor Hospital, Bangor University, Wrexham, U.K.Diabetes Clinical Trials, Chattanooga, TN.Diabetes, Endocrinology and General Medicine, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, U.K.Protenium Clinical Research, Hurst, TX.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.Atlanta Diabetes Associates, Atlanta, GA.

Pub Type(s)

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

Language

eng

PubMed ID

28483786

Citation

Bowering, Keith, et al. "Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: the Onset 2 Trial." Diabetes Care, vol. 40, no. 7, 2017, pp. 951-957.
Bowering K, Case C, Harvey J, et al. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Diabetes Care. 2017;40(7):951-957.
Bowering, K., Case, C., Harvey, J., Reeves, M., Sampson, M., Strzinek, R., ... Bode, B. W. (2017). Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Diabetes Care, 40(7), pp. 951-957. doi:10.2337/dc16-1770.
Bowering K, et al. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: the Onset 2 Trial. Diabetes Care. 2017;40(7):951-957. PubMed PMID: 28483786.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. AU - Bowering,Keith, AU - Case,Christopher, AU - Harvey,John, AU - Reeves,Michael, AU - Sampson,Michael, AU - Strzinek,Robert, AU - Bretler,Ditte-Marie, AU - Bang,Rikke Beck, AU - Bode,Bruce W, Y1 - 2017/05/08/ PY - 2016/08/16/received PY - 2017/04/14/accepted PY - 2017/5/10/pubmed PY - 2017/12/29/medline PY - 2017/5/10/entrez SP - 951 EP - 957 JF - Diabetes care JO - Diabetes Care VL - 40 IS - 7 N2 - OBJECTIVE: This multicenter, double-blind, treat-to-target, phase 3 trial evaluated the efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp) in adults with type 2 diabetes receiving basal insulin and oral antidiabetic agents. RESEARCH DESIGN AND METHODS: The primary end point was HbA1c change from baseline after 26 weeks' treatment. After an 8-week run-in to optimize basal insulin, subjects were randomized (1:1) to mealtime faster aspart (n = 345) or IAsp (n = 344), titrated using a simple daily patient-driven algorithm, plus insulin glargine U100 and metformin. RESULTS: HbA1c change was -1.38% (faster aspart) and -1.36% (IAsp); mean HbA1c was 6.6% for both groups. Faster aspart demonstrated noninferiority versus IAsp in reducing HbA1c (estimated treatment difference [ETD] [95% CI] -0.02% [-0.15; 0.10]). Both treatments improved postprandial plasma glucose (PPG) control; the PPG increment (liquid meal test) was statistically significant in favor of faster aspart after 1 h (ETD [95% CI] -0.59 mmol/L [-1.09; -0.09]; -10.63 mg/dL [-19.56; -1.69]; P = 0.0198), but not after 2-4 h. Change from baseline in fasting plasma glucose, body weight, and overall severe/blood glucose-confirmed hypoglycemia rates (rate ratio [RR] [95% CI] 1.09 [0.88; 1.36]) were similar between treatments. Postmeal hypoglycemia (0-2 h) rates were 2.27 (faster aspart) and 1.49 (IAsp) per patient-year of exposure (RR [95% CI] 1.60 [1.13; 2.27]). CONCLUSIONS: Faster aspart and IAsp were confirmed noninferior in a basal-bolus regimen regarding change from baseline in HbA1c. Faster aspart improved 1-h PPG with no differences in 2-4-h PPG versus IAsp. Overall hypoglycemia rates were similar except for an increase in 0-2-h postmeal hypoglycemia with faster aspart. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/28483786/Faster_Aspart_Versus_Insulin_Aspart_as_Part_of_a_Basal_Bolus_Regimen_in_Inadequately_Controlled_Type_2_Diabetes:_The_onset_2_Trial_ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&pmid=28483786 DB - PRIME DP - Unbound Medicine ER -