Wenying Yang1, Canan Ersoy2, Guixia Wang3, Shandong Ye4, Jun Liu5, Heng Miao6, Arthur Asirvatham7, Shanti Werther8, Priti Kadu9, Francis Chow10. 1. China-Japan Friendship Hospital, East Yinghuayuan Street, Hepingli, Beijing 100029, China. Electronic address: ywying_1010@163.com. 2. Division of Endocrinology and Metabolism, School of Medicine, Uludag University, Bursa, Turkey. Electronic address: ecanan@uludag.edu.tr. 3. Department of Endocrinology and Metabolism, The First Hospital of Jilin University, Changchun, Jilin Province 130021, China. Electronic address: gwang168@jlu.edu.cn. 4. School of Medicine, Shandong University, Jinan, Shandong, China; Department of Endocrinology, Anhui Provincial Hospital Affiliated to Anhui Medical University, Hefei, China. 5. Department of Endocrinology, Shanghai Fifth People's Hospital Affiliated to Fudan University, 801 Heqing Road, Minhang District, Shanghai 200240, China. 6. The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: miaoheng@njmu.edu.cn. 7. Department of Medicine, Government Medical College, Madurai, Tamil Nadu, India. 8. Novo Nordisk A/S, Søborg, Denmark. Electronic address: scw@novonordisk.com. 9. Novo Nordisk A/S, Søborg, Denmark. 10. Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China. Electronic address: b410773@mailserv.cuhk.edu.hk.
Abstract
AIMS: To compare the efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) administered three times daily (TID) vs. twice daily (BID), plus metformin, in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on basal insulin ± 1 oral antidiabetic drug (OAD). METHODS: Randomised, multinational, open-label, treat-to-target trial. Subjects inadequately controlled (HbA1c 7.5-10.0%) on basal insulin and metformin ± 1 OAD were randomised to BIAsp30 TID (n = 220) or BIAsp30 BID (n = 217). Primary endpoint was change from baseline in HbA1c after 24 weeks of treatment. RESULTS: Most (400/437, 91.5%) subjects completed the trial. The majority (276/400 [69.0%]) were from the China region. After 24 weeks, HbA1c decreased comparably in both BIAsp 30 groups (-1.7% vs. -1.6% [-19 vs. -18 mmol/mol], for TID and BID dosing, respectively; estimated treatment difference: -0.09% [-0.23; 0.06]95% CI, -1 mmol/mol [-3; 1], p = 0.26). Safety profiles, including number of subjects experiencing hypoglycaemia, were similar. CONCLUSIONS: BIAsp 30 administered either TID or BID with metformin was a safe and effective option when intensifying treatment after failure of basal insulin and OADs in patients with T2DM. Adding a third injection at lunchtime may be preferable if HbA1c remains above target, if the lunchtime meal is the largest meal of the day, or if persistent postprandial hyperglycaemia after lunch is observed. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT02582242.
RCT Entities:
AIMS: To compare the efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) administered three times daily (TID) vs. twice daily (BID), plus metformin, in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on basal insulin ± 1 oral antidiabetic drug (OAD). METHODS: Randomised, multinational, open-label, treat-to-target trial. Subjects inadequately controlled (HbA1c 7.5-10.0%) on basal insulin and metformin ± 1 OAD were randomised to BIAsp30 TID (n = 220) or BIAsp30 BID (n = 217). Primary endpoint was change from baseline in HbA1c after 24 weeks of treatment. RESULTS: Most (400/437, 91.5%) subjects completed the trial. The majority (276/400 [69.0%]) were from the China region. After 24 weeks, HbA1c decreased comparably in both BIAsp 30 groups (-1.7% vs. -1.6% [-19 vs. -18 mmol/mol], for TID and BID dosing, respectively; estimated treatment difference: -0.09% [-0.23; 0.06]95% CI, -1 mmol/mol [-3; 1], p = 0.26). Safety profiles, including number of subjects experiencing hypoglycaemia, were similar. CONCLUSIONS: BIAsp 30 administered either TID or BID with metformin was a safe and effective option when intensifying treatment after failure of basal insulin and OADs in patients with T2DM. Adding a third injection at lunchtime may be preferable if HbA1c remains above target, if the lunchtime meal is the largest meal of the day, or if persistent postprandial hyperglycaemia after lunch is observed. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT02582242.