Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial
| Autor: | Keith Bowering, Bruce W. Bode, Mike Sampson, John N Harvey, Rikke Beck Bang, Ditte-Marie Bretler, Michael L. Reeves, Robert Strzinek, Christopher Case |
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| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
endocrine system diseases Endocrinology Diabetes and Metabolism 030209 endocrinology & metabolism Type 2 diabetes Hypoglycemia Gastroenterology law.invention Insulin aspart 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine Diabetes mellitus Internal Medicine medicine 030212 general & internal medicine Advanced and Specialized Nursing business.industry Insulin glargine nutritional and metabolic diseases medicine.disease Metformin Endocrinology Postprandial business medicine.drug |
| Zdroj: | Diabetes Care. 40:951-957 |
| ISSN: | 1935-5548 0149-5992 |
| DOI: | 10.2337/dc16-1770 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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