Efficacy and safety of dapagliflozin in addition to insulin therapy in Japanese patients with type 2 diabetes: Results of the interim analysis of 16-week double-blind treatment period

Journal of Diabetes Investigation

Volumn 7, Issue 4, 2016, Pages 555-564

  Araki, Eiichi ^a   Onishi, Yukiko ^b   Asano, Michiko ^c   Kim, Hyosung ^c   Ekholm, Ella ^d   Johnsson, Eva ^d   Yajima, Toshitaka ^c  

^a KUMAMOTO UNIVERSITY   (Japan)

^b INSTITUTE FOR ADULT DISEASES   (Japan)

^c ASTRAZENECA   (United Kingdom)

^d ASTRAZENECA R AND D   (Sweden)

Author keywords

Add on to insulin; Dapagliflozin; Sodium glucose co transporter 2 inhibitor

Indexed keywords

DAPAGLIFLOZIN; GLUCOSE; HEMOGLOBIN A1C; INSULIN; PLACEBO;

ADULT; ARTICLE; BODY WEIGHT; CHOLELITHIASIS; CONTROLLED STUDY; DIET RESTRICTION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; GENITAL TRACT INFECTION; GLUCOSE BLOOD LEVEL; HAND FRACTURE; HEMATOCRIT; HUMAN; HYPOGLYCEMIA; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OSTEOCHONDROSIS; PARALLEL DESIGN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; URINARY TRACT INFECTION;

EID: 84977589113     PISSN: 20401116     EISSN: 20401124     Source Type: Journal    
DOI: 10.1111/jdi.12453     Document Type: Article

References (28)

1. Matthaei S, Stumvoll M, Kellerer M, et al. Pathophysiology and pharmacological treatment of insulin resistance. Endocr Rev 2000; 21: 585–618.
2. Meier JJ, Butler PC. Insulin secretion. In: DeGroot LJ, Jameson JL (eds). Endocrinology, 5th edn. Philadelphia, PA: Elsevier Saunders, 2005; 961–973.
3. Stratton IM, Adler AI, Neil HA, et al. Association of glycemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000; 321: 405–412.
4. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in subjects with type 2 diabetes (UKPDS 33). Lancet 1998; 352: 837–853.
5. Yokoyama H, Matsushima M, Kawai K, et al. Low incidence of cardiovascular events in Japanese patients with Type 2 diabetes in primary care settings: a prospective cohort study (JDDM 20). Diabet Med 2011; 28: 1221–1228.
6. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight subjects with type 2 diabetes (UKPDS 34). Lancet 1998; 352: 854–865.
7. Kanatsuka A, Kawai K, Hirao K, et al. Research on antihyperglycemic drug therapies in patients with type 2 diabetes mellitus in Japan (II): the effectiveness on glycemic control (JDDM7). J Jpn Diabetes Soc 2006; 49: 919–927 (Japanese).
8. Heine RJ, Van Gaal LF, Johns D, et al. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med 2005; 143: 559–569.
9. Groop LC, Pelkonen R, Koskimies S, et al. Secondary failure to treatment with oral antidiabetic agents in non-insulin-dependent diabetes. Diabetes Care 1986; 9: 129–133.
10. Turner R, Cull C, Holman R. United Kingdom Prospective Diabetes Study 17: a 9-year update of a randomized, controlled trial on the effect of improved metabolic control on complications in non-insulin-dependent diabetes mellitus. Ann Intern Med 1996; 124: 136–145.
11. Zhang M, Tsiatis AA, Davidian M. Improving efficiency of inferences in randomized clinical trials using auxiliary covariates. Biometrics 2008; 64: 707–715.
12. Henry RR, Murray AV, Nauck MA, et al. Response to dapagliflozin by baseline HbA1c in head-to-head comparisons. Diabetes 2013; 62(suppl 1): A289.
13. Ferrannini E, Ramos SJ, Salsali A, et al. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care 2010; 33: 2217–2224.
14. Kaku K, Kiyosue A, Inoue S, et al. Efficacy and safety of dapagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled by diet and exercise. Diabetes Obes Metab 2014; 16: 1102–1110.
15. Bailey CJ, Gross JL, Hennicken D, et al. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC Med 2013; 11: 43.
16. Henry RR, Murray AV, Marmolejo MH, et al. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract 2012; 66: 446–456.
17. Strojek K, Yoon KH, Hruba V, et al. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab 2011; 13: 928–938.
18. Rosenstock J, Vico M, Wei L, et al. Effects of dapagliflozin, an SGLT2 inhibitor, on HbA1c, body weight, and hypoglycemia risk in patients with Type2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care 2012; 35: 1473–1478.
19. Wilding JPH, Woo V, Soler NG, et al. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin. Ann Intern Med 2012; 156: 405–415.
20. Wilding JPH, Woo V, Rohwedder K, et al. Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Diabetes Obes Metab 2014; 16: 124–136.
21. Kaku K, Inoue S, Matsuoka O, et al. Efficacy and safety of dapagliflozin as a monotherapy for type 2 diabetes mellitus in Japanese patients with inadequate glycaemic control: a phase II multicentre, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab 2013; 15: 432–440.
22. Kaku K, Maegawa H, Tanizawa Y, et al. Dapagliflozin as monotherapy or combination therapy in Japanese patients with type 2 diabetes: an open-label study. Diabetes Ther 2014; 5: 415–433.
23. Bolinder J, Ljunggren Ö, Kullberg J, et al. 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; 97: 1020–1031.
24. Janssen I, Heymsfield SB, Allison DB, et al. Body mass index and waist circumference independently contribute to the prediction of nonabdominal, abdominal subcutaneous, and visceral fat. Am J Clin Nutr 2002; 75: 683–688.
25. Wilding JP. The role of the kidneys in glucose homeostasis in type 2 diabetes: clinical implications and therapeutic significance through sodium glucose co-transporter 2 inhibitors. Metabolism 2014; 63: 1228–1237.
26. Wilding JPH, Norwood P, T'joen C, et al. A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers; applicability of a novel insulin-independent treatment. Diabetes Care 2009; 32: 1656–1662.
27. Shah BR, Hux JE. Quantifying the risk of infectious diseases for people with diabetes. Diabetes Care 2003; 26: 510–513.
28. Kalra S. Sodium glucose co-transporter-2 (SGLT2) inhibitors: a review of their basic and clinical pharmacology. Diabetes Ther 2014; 5: 355–366.