Dapagliflozin on Hyperlipidemia and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS Study)

Summary

The investigators will investigate whether dapagliflozin (FORXIGA) might improve lipoprotein metabolism as well as hyperglycemia in Japanese patients with type II diabetes mellitus whose HbA1c levels are less than 7.0% (from 20 to 65 years of age). The investigators will examine changes of fasting lipoprotein profile including TG, TC, HDL-C, apoB-48 and RemL-C before and after the 8 weeks administration of dapagliflozin.

Timeline

Start

2015-07-01

Primary completion

2017-12-31

Completion

2018-08-31

Publications

• Background Hanada H, Mugii S, Okubo M, Maeda I, Kuwayama K, Hidaka Y, Kitazume-Taneike R, Yamashita T, Kawase R, Nakaoka H, Inagaki M, Yuasa-Kawase M, Nakatani K, Tsubakio-Yamamoto K, Masuda D, Ohama T, Matsuyama A, Ishigami M, Nishida M, Komuro I, Yamashita S. Establishment of chemiluminescence enzyme immunoassay for apolipoprotein B-48 and its clinical applications for evaluation of impaired chylomicron remnant metabolism. Clin Chim Acta. 2012 Jan 18;413(1-2):160-5. doi: 10.1016/j.cca.2011.09.013. Epub 2011 Sep 19.
• Background Masuda D, Sakai N, Sugimoto T, Kitazume-Taneike R, Yamashita T, Kawase R, Nakaoka H, Inagaki M, Nakatani K, Yuasa-Kawase M, Tsubakio-Yamamoto K, Ohama T, Nakagawa-Toyama Y, Nishida M, Ishigami M, Masuda Y, Matsuyama A, Komuro I, Yamashita S. Fasting serum apolipoprotein B-48 can be a marker of postprandial hyperlipidemia. J Atheroscler Thromb. 2011;18(12):1062-70. doi: 10.5551/jat.10470. Epub 2011 Sep 24.
• Background Okubo M, Hanada H, Matsui M, Hidaka Y, Masuda D, Sakata Y, Yamashita S. Serum apolipoprotein B-48 concentration is associated with a reduced estimated glomerular filtration rate and increased proteinuria. J Atheroscler Thromb. 2014;21(9):974-82. doi: 10.5551/jat.23309. Epub 2014 Jun 2.
• Background Mugii S, Hanada H, Okubo M, Masuda D, Takeoka K, Hidaka Y, Ohama T, Matsuyama A, Nakagawa-Toyama Y, Nishida M, Ishigami M, Komuro I, Yamashita S. Thyroid function influences serum apolipoprotein B-48 levels in patients with thyroid disease. J Atheroscler Thromb. 2012;19(10):890-6. doi: 10.5551/jat.12757. Epub 2012 Jul 4.
• Background Nakatani K, Sugimoto T, Masuda D, Okano R, Oya T, Monden Y, Yamashita T, Kawase R, Nakaoka H, Inagaki M, Yuasa-Kawase M, Tsubakio-Yamamoto K, Ohama T, Nishida M, Ishigami M, Komuro I, Yamashita S. Serum apolipoprotein B-48 levels are correlated with carotid intima-media thickness in subjects with normal serum triglyceride levels. Atherosclerosis. 2011 Sep;218(1):226-32. doi: 10.1016/j.atherosclerosis.2011.05.009. Epub 2011 May 18.
• Background Masuda D, Sugimoto T, Tsujii K, Inagaki M, Nakatani K, Yuasa-Kawase M, Tsubakio-Yamamoto K, Ohama T, Nishida M, Ishigami M, Kawamoto T, Matsuyama A, Sakai N, Komuro I, Yamashita S. Correlation of fasting serum apolipoprotein B-48 with coronary artery disease prevalence. Eur J Clin Invest. 2012 Sep;42(9):992-9. doi: 10.1111/j.1365-2362.2012.02687.x. Epub 2012 May 15.
• Background Ji L, Ma J, Li H, Mansfield TA, T'joen CL, Iqbal N, Ptaszynska A, List JF. Dapagliflozin as monotherapy in drug-naive Asian patients with type 2 diabetes mellitus: a randomized, blinded, prospective phase III study. Clin Ther. 2014 Jan 1;36(1):84-100.e9. doi: 10.1016/j.clinthera.2013.11.002. Epub 2013 Dec 28.
• Background Kaku K, Maegawa H, Tanizawa Y, Kiyosue A, Ide Y, Tokudome T, Hoshino Y, Yang J, Langkilde AM. Dapagliflozin as monotherapy or combination therapy in Japanese patients with type 2 diabetes: an open-label study. Diabetes Ther. 2014 Dec;5(2):415-33. doi: 10.1007/s13300-014-0086-7. Epub 2014 Oct 24.
• Background Bolinder J, Ljunggren O, Kullberg J, Johansson L, Wilding J, Langkilde AM, Sugg J, Parikh S. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012 Mar;97(3):1020-31. doi: 10.1210/jc.2011-2260. Epub 2012 Jan 11.

Drugs

Indications