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Addition of biphasic insulin aspart 30 to optimized metformin and pioglitazone treatment of type 2 diabetes mellitus: The ACTION Study (Achieving Control Through Insulin plus Oral ageNts)
Author(s) -
Raskin P.,
Matfin G.,
Schwartz S. L.,
Chaykin L.,
Chu P.L.,
Braceras R.,
Wynne A.
Publication year - 2009
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2007.00796.x
Subject(s) - pioglitazone , medicine , metformin , endocrinology , insulin , diabetes mellitus , type 2 diabetes , insulin aspart , type 2 diabetes mellitus
Aim: Efficacy and safety of biphasic insulin aspart (BIAsp 30, 30% short‐acting and 70% intermediate‐acting insulin aspart) added to an optimized treatment of metformin and pioglitazone (met/pio) were compared with treatment with optimized met/pio in type 2 diabetes patients. Methods: This randomized, 34‐week, parallel‐group study enrolled insulin‐naive, type 2 diabetes patients (HbA 1c 7.5–12.0%) previously using two oral antidiabetic (OAD) agents. During an 8‐week run‐in period, treatment was changed to met/pio and doses were adjusted up to 2500 mg/day and 30 or 45 mg/day respectively. Subjects either continued met/pio alone or added BIAsp 30 initiated at 6 units twice daily and titrated to target plasma glucose (PG) (4.4–6.1 mmol/l). Results: At end‐of‐study, subjects treated with BIAsp 30+met/pio (n = 93) had a mean (±s.d.) HbA 1c reduction significantly greater than treatment with met/pio (n = 88) (1.5% ± 1.1 vs. 0.2% ± 0.9, p < 0.0001 between groups). Subjects treated with BIAsp 30+met/pio were more likely to reach The American Association of Clinical Endocrinologists and European Association for the Study of Diabetes/American Diabetes Association HbA 1c targets of ≤6.5 and <7.0%, respectively, than with met/pio only (HbA 1c ≤6.5%: 59 vs. 12%; HbA 1c <7.0%: 76 vs. 24%). At end‐of‐study, self‐monitored glucose profile values at all eight daily time points were significantly less for the BIAsp 30+met/pio group compared with the met/pio group, and minor hypoglycaemia (defined as PG < 3.1 mmol/l) was more frequent (8.3 vs. 0.1 events/year, p < 0.001). Both groups gained weight during treatment (BIAsp 30+met/pio, 4.6 ± 4.3 kg; met/pio, 0.8 ± 3.2 kg; p < 0.001). Conclusion: Addition of insulin in type 2 patients treated with met/pio is an effective way to achieve glycaemic targets. Treatment with BIAsp 30+met/pio achieved significantly greater reduction in HbA 1c , as compared with met/pio alone. In patients with type 2 diabetes poorly controlled by 2 OADs, more achieved glycaemic targets using BIAsp 30+met/pio than using met/pio alone.