Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial

• Published in: Diabetes care Vol. 40; no. 7; pp. 951 - 957
• Main Authors: Bowering, Keith, Case, Christopher, Harvey, John, Reeves, Michael, Sampson, Michael, Strzinek, Robert, Bretler, Ditte-Marie, Bang, Rikke Beck, Bode, Bruce W.
• Format: Journal Article
• Language: English
• Published: United States American Diabetes Association 01.07.2017
• Subjects: Adults; Aged; Antidiabetics; Blood glucose; Blood Glucose - metabolism; Body weight; Diabetes; Diabetes mellitus; Diabetes Mellitus, Type 2 - drug therapy; Double-Blind Method; Endpoint Determination; Fasting; Female; Glucose; Glycated Hemoglobin A - metabolism; Humans; Hypoglycemia; Hypoglycemia - drug therapy; Hypoglycemic Agents - therapeutic use; Insulin; Insulin - therapeutic use; Insulin Aspart - therapeutic use; Insulin Glargine - therapeutic use; Laboratory testing; Male; Meals; Medical treatment; Metformin; Metformin - therapeutic use; Middle Aged; Postprandial Period; Research design; Statistical analysis
• ISSN: 0149-5992; 1935-5548; 1935-5548
• DOI: 10.2337/dc16-1770

This multicenter, double-blind, treat-to-target, phase 3 trial evaluated the efficacy and RESEARCH DESIGN AND METHODS: The primary end point was HbA 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 ( = 345) or IAsp ( = 344), titrated using a simple daily patient-driven algorithm, plus insulin glargine U100 and metformin. HbA change was -1.38% (faster aspart) and -1.36% (IAsp); mean HbA was 6.6% for both groups. Faster aspart demonstrated noninferiority versus IAsp in reducing HbA (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]; = 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]). Faster aspart and IAsp were confirmed noninferior in a basal-bolus regimen regarding change from baseline in HbA . 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.