Improved glycaemic control with minimal hypoglycaemia and no weight change with the once-daily human glucagon-like peptide-1 analogue liraglutide as add-on to sulphonylurea in Japanese patients with type 2 diabetes

Diabetes, Obesity and Metabolism

Volumn 12, Issue 4, 2010, Pages 341-347

  Kaku, K ^a   Rasmussen, M F ^b   Clauson, P ^b   Seino, Y ^c  

^a KAWASAKI MEDICAL SCHOOL   (Japan)

^b NOVO NORDISK A S   (Denmark)

^c KANSAI ELECTRIC POWER CO   (Japan)

Author keywords

Glucagon like peptide 1; Liraglutide; Sulphonylurea; Type 2 diabetes

Indexed keywords

GLIBENCLAMIDE; GLICLAZIDE; GLIMEPIRIDE; GLUCOSE; HEMOGLOBIN A1C; LIRAGLUTIDE; PLACEBO;

ADD ON THERAPY; ADULT; AREA UNDER THE CURVE; ARTICLE; BODY MASS; BODY WEIGHT; CALCITONIN BLOOD LEVEL; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; GASTROINTESTINAL SYMPTOM; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; JAPANESE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREATITIS; PULSE RATE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT;

EID: 77954360414     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/j.1463-1326.2009.01194.x     Document Type: Article

References (34)

1. Fukushima M, Suzuki H, Seino Y. Insulin secretion capacity in the development from normal glucose tolerance to type 2 diabetes. Diab Res Clin Pract 2004, 66S:S37-S43.
2. Fukushima M, Usami M, Ikeda M, Nakai Y, Taniguchi A, Matsuura T. Insulin secretion and insulin sensitivity at different stages of glucose tolerance: a cross-sectional trial of Japanese type 2 diabetes. Metabolism 2004, 53:831-835.
3. Haffner SM, Howard G, Mayer E, Bergman RN, Savage PJ, Rewers M. Insulin sensitivity and acute insulin response in African-Americans, non-Hispanic whites, and Hispanics with NIDDM: the insulin resistance atherosclerosis study. Diabetes 1997, 46:63-69.
4. Nakagami T, Qiao Q, Carstensen B, Nhr-Hansen C, Hu G, Tuomilehto J. Age, body mass index and type 2 diabetes-associations modified by ethnicity. Diabetologia 2003, 46:1063-1070. The DECODE-DECODA Study Group
5. Sone H, Yoshimura Y, Ito H, Ohashi Y, Yamada N. Energy intake and obesity in Japanese patients with type 2 diabetes. Lancet 2004, 363:248-249. Japan Diabetes Complications Study Group
6. Evidence based clinical practice guidelines for the treatment of diabetes mellitus in Japan. J Japan Diab Soc 2006, 49:409-415. Japan Diabetes Society
7. Kawamori R. Efficacy and safety of insulin glargine in concurrent use with oral hypoglycaemic agents for the treatment of type 2 diabetes patients. Rinsho Iyaku 2003, 19:445-464.
8. Fujimoto WY, Akanuma Y, Kanazawa Y, Mashiko S, Leonetti D, Wahl P. Plasma insulin levels in Japanese and Japanese-American men with type 2 diabetes may be related to the occurrence of cardiovascular disease. Diab Res Clin Pract 1989, 6:121-127.
9. Matsuzawa Y, Inoue S, Ikeda Y, Sakata T, Saitoh K, Satoh Y. Atarashii himan nohantei to himanshou no shindan kijun [The new diagnostic criteria of obesity]. J Japan Soc Study Obes 2002, 6:18-28.
10. Deurenberg P, Deurenberg-Yap M, Guricci S. Asians are different from Caucasians and from each other in their body mass index/body fat per cent relationship. Obes Rev 2002, 3:141-146.
11. Viberti G, Lachin J, Holman R, Zinman B, Haffner S, Kravitz B. A Diabetes Outcome Progression Trial (ADOPT): baseline characteristics of type 2 diabetic patients in North America and Europe. Diabet Med 2006, 23:1289-1294. for the, ADOPT Study Group
12. Buse J, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett J. For the LEAD 6 study group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet 2009, 374:39-47.
13. Russell-Jones D, Vaag A, Schmitz O, Sethi B, Lalic NM, Antic S. on behalf of the LEAD-5 (Liraglutide Effect and Action in Diabetes 5) met+SU Study Group. Liraglutide vs insulin glargine and placebo in combination with metformin and sulphonylurea therapy in type 2 diabetes mellitus: a randomised controlled trial (LEAD-5 met+SU). Diabetologia 2009, 52:4026-4055.
14. Zinman B, Gerich J, Buse J, Lewin A, Schwartz SL, Raskin P. LEAD-4 Study Investigators. Efficacy and safety of the human GLP-1 analog liraglutide in combination with metformin and TZD in patients with type 2 diabetes mellitus (LEAD-4 Met+TZD). Diabetes Care 2009, 32:1224-1230.
15. Garber A, Henry R, Ratner R, Garcia-Hernandez PA, Rodriguez-Pattzi H, Olvera-Alvarez I. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet 2009, 373:473-481.
16. Marre M, Shaw J, Brandle M, Wan Bebakar WM, Kamaruddin NA, Strand J. The LEAD-1 SU study group. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with type 2 diabetes (LEAD-1 SU). Diabet Med 2009, 26:268-278.
17. Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care 2009, 32:84-90.
18. DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron ADI. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care 2005, 28:1092-1100.
19. Buse JB, Henry RR, Han J, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycaemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care 2004, 27:2628-2635.
20. Kendall DM, Riddle MC, Rosenstock J, Zhuang D, Kim DD, Fineman MS. Effects of exenatide (exendin-4) on glycaemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care 2005, 28:1083-1091.
21. Højberg PV, Vilsbøll T, Zander M, Knop FK, Krarup T, Vølund A. Four weeks of near-normalization of blood glucose has no effect on postprandial GLP-1 and GIP secretion, but augments pancreatic B-cell responsiveness to a meal in patients with type 2 diabetes. Diabet Med 2008, 25:1268-1275.
22. Vilsbøll T, Krarup T, Madsbad S, Holst JJ. Defective amplification of the late phase insulin response to glucose by GIP in obese type 2 diabetic patients. Diabetologia 2002, 45:1111-1119.
23. Chang AM, Jakobsen G, Sturis J, Smith MJ, Bloem CJ, An B. The GLP-1 derivative NN2211 restores beta-cell sensitivity to glucose in type 2 diabetic patients after a single dose. Diabetes 2003, 52:1786-1791.
24. Seino Y, Rasmussen MF, Zdravkovic M, Kaku K. Dose-dependent improvement in glycemia with once-daily liraglutide without hypoglycemia or weight gain: a double-blind, randomized, controlled trial in Japanese patients with type 2 diabetes. Diab Res Clin Pract 2008, 81:161-168.
25. Kobayashi M, Yamazaki K, Hirao K, Oishi HM, Kanatsuka A, Yamauchi M. The status of diabetes control and antidiabetic drug therapy in Japan-a cross-sectional survey of 17,000 patients with diabetes mellitus (JDDM 1). Diab Res Clin Pract 2006, 73:198-204.
26. Zhou J, Wang X, Pineyro MA, Egan JM. Glucagon-like peptide 1 and exendin-4 convert pancreatic AR42J cells into glucagon- and insulin-producing cells. Diabetes 1999, 48:2358-2366.
27. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998, 352:837-853. UK Prospective Diabetes Study (UKPDS) Group
28. Russell-Jones D, Khan R. Insulin-associated weight gain in diabetes-causes, effects and coping strategies. Diabetes Obesity Metab 2007, 6:799-812.
29. Yki-Järvinen H, Ryysy L, Kauppila M, Kujansuu E, Lahti J, Marjanen T. Effect of obesity on the response to insulin therapy in noninsulin-dependent diabetes mellitus. J Clin Endocrinol Metab 1997, 82:4037-4043.
30. The Examination Committee of criteria for 'Obesity Disease' in Japan. Circ J 2004, 66:987-992. Japan Society for the Study of Obesity
31. Russell-Jones D, Shaw JE, Brandle M, Matthews D, Frid A, Zdravkovic M. The once-daily human GLP-1 analog liraglutide reduces body weight in subjects with type 2 diabetes, irrespective of body mass index at baseline. Diabetes 2008, 57:A593. (Suppl. 1):
32. Irie S, Matsumura Y, Zdravkovic M, Jacobsen LV, Kageyama S. Safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily GLP-1 analogue liraglutide in healthy Japanese subjects. Diabetes 2007, 56:A540. (Suppl. 1):
33. Juhl CB, Hollingdal M, Sturis J, Jakobsen G, Agersø H, Veldhuis J. Bedtime administration of NN2211, a long-acting GLP-1 derivative, substantially reduces fasting and postprandial glycemia in type 2 diabetes. Diabetes 2002, 51:424-429.
34. Seino Y, Kaku K, Nishijima K, Rasmussen MF, Zdravkovic M, Kristensen P. Once daily dosing of the long acting GLP-1 analog liraglutide significantly improves glycaemic control by reducing both fasting and post-prandial glucose levels in Japanese subjects with type 2 diabetes. Diabetes 2007, 56:A138. (Suppl. 1):