Y Terauchi1, M Koyama2, X Cheng3, M Sumi4, M C Riddle5, G B Bolli6, T Hirose7. 1. Yokohama City University Graduate School of Medicine, Department of Endocrinology and Metabolism, 3-9 Fukuura, Kanazawa-ku, 236-0004 Yokohama, Japan. Electronic address: terauchi@yokohama-cu.ac.jp. 2. Sanofi, 3-20-2 Nishi-Shinjuku, Shinjuku-ku, 163-1488 Tokyo, Japan. Electronic address: masayoshi.koyama@sanofi.com. 3. Sanofi, 112 Jianguo Road, Chaoyang District, 100022 Beijing, China. Electronic address: cecilia.cheng@sanofi.com. 4. Sanofi, 3-20-2 Nishi-Shinjuku, Shinjuku-ku, 163-1488 Tokyo, Japan. Electronic address: mariko.sumi@sanofi.com. 5. Oregon Health and Science University, 3181 Southwest Sam Jackson Park Road, 97239 Portland, OR, USA. Electronic address: riddlem@ohsu.edu. 6. Perugia University School of Medicine, Ospedale Santa Maria della Misericordia, 06132 Perugia, Italy. Electronic address: geremia.bolli@unipg.it. 7. Toho University School of Medicine, 5 Chome-21-16 Omorinishi, Ota, 143-8540 Tokyo, Japan. Electronic address: takahisa.hirose@med.toho-u.ac.jp.
Abstract
AIMS: To compare insulin glargine 300 U/mL (Gla-300) with glargine 100 U/mL (Gla-100) in Japanese adults with uncontrolled type 2 diabetes on basal insulin andoral anti-hyperglycaemic drugs over 12 months. METHODS: EDITION JP 2 was a randomised, open-label, phase 3 study. Following a 6-month treatment period, participants continued receiving previously assigned once daily Gla-300 or Gla-100, plus oral anti-hyperglycaemic drugs, in a 6-month extension period. Glycaemic control, hypoglycaemia and adverse events were assessed. RESULTS: The 12-month completion rate was 88% for Gla-300 and 96% for Gla-100, with comparable reasons for discontinuation. Mean HbA1c decrease from baseline to month 12 was 0.3% in both groups. Annualised rates of confirmed (≤3.9mmol/L [≤70mg/dL]) or severe hypoglycaemia were lower with Gla-300 than Gla-100 (nocturnal [00:00-05:59h]: rate ratio 0.41; 95% confidence interval: 0.18 to 0.92; anytime [24h]: rate ratio 0.64; 95% confidence interval: 0.44 to 0.94). Cumulative number of hypoglycaemic events was lower with Gla-300 than Gla-100. Adverse event profiles were comparable between treatments. CONCLUSION: Over 12 months, Gla-300-treated participants achieved sustained glycaemic control and experienced less hypoglycaemia, particularly at night, versus Gla-100, supporting 6-month results.
RCT Entities:
AIMS: To compare insulin glargine 300 U/mL (Gla-300) with glargine 100 U/mL (Gla-100) in Japanese adults with uncontrolled type 2 diabetes on basal insulin and oral anti-hyperglycaemic drugs over 12 months. METHODS: EDITION JP 2 was a randomised, open-label, phase 3 study. Following a 6-month treatment period, participants continued receiving previously assigned once daily Gla-300 or Gla-100, plus oral anti-hyperglycaemic drugs, in a 6-month extension period. Glycaemic control, hypoglycaemia and adverse events were assessed. RESULTS: The 12-month completion rate was 88% for Gla-300 and 96% for Gla-100, with comparable reasons for discontinuation. Mean HbA1c decrease from baseline to month 12 was 0.3% in both groups. Annualised rates of confirmed (≤3.9mmol/L [≤70mg/dL]) or severe hypoglycaemia were lower with Gla-300 than Gla-100 (nocturnal [00:00-05:59h]: rate ratio 0.41; 95% confidence interval: 0.18 to 0.92; anytime [24h]: rate ratio 0.64; 95% confidence interval: 0.44 to 0.94). Cumulative number of hypoglycaemic events was lower with Gla-300 than Gla-100. Adverse event profiles were comparable between treatments. CONCLUSION: Over 12 months, Gla-300-treated participants achieved sustained glycaemic control and experienced less hypoglycaemia, particularly at night, versus Gla-100, supporting 6-month results.
Authors: Timothy S Bailey; Jasmanda Wu; Fang L Zhou; Rishab A Gupta; Arjun A Menon; Paulos Berhanu; Jukka Westerbacka; John Van Vleet; Lawrence Blonde Journal: Diabetes Obes Metab Date: 2019-07-18 Impact factor: 6.577
Authors: Antonio Perez; Francisco Javier Carrasco-Sánchez; Carlos González; José Miguel Seguí-Ripoll; Carlos Trescolí; Javier Ena; Mireia Borrell; Ricardo Gomez Huelgas Journal: BMJ Open Diabetes Res Care Date: 2020-09