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

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: Keith Bowering, Christopher Case, John Harvey, Michael Reeves, Michael Sampson, Robert Strzinek, Ditte-Marie Bretler, Rikke Beck Bang, Bruce W Bode
• Journal: Diabetes care (Diabetes Care) Vol. 40 Issue 7 Pg. 951-957 (07 2017) ISSN: 1935-5548 [Electronic] United States
• PMID: 28483786 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2017 by the American Diabetes Association.

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin
• Insulin Glargine
• Metformin
• Insulin Aspart

Topics

• Aged
• Blood Glucose (metabolism)
• Diabetes Mellitus, Type 2 (drug therapy)
• Double-Blind Method
• Endpoint Determination
• Female
• Glycated Hemoglobin (metabolism)
• Humans
• Hypoglycemia (drug therapy)
• Hypoglycemic Agents (therapeutic use)
• Insulin (therapeutic use)
• Insulin Aspart (therapeutic use)
• Insulin Glargine (therapeutic use)
• Male
• Meals
• Metformin (therapeutic use)
• Middle Aged
• Postprandial Period