Monotherapy with the once weekly GLP-1 receptor agonist dulaglutide for 12 weeks in Japanese patients with type 2 diabetes: Dose-dependent effects on glycaemic control in a randomised, Double-blind, Placebo-controlled study

Endocrine Journal

Volumn 61, Issue 10, 2014, Pages 949-959

  Terauchi, Yasuo ^a   Satoi, Yoichi ^b   Takeuchi, Masakazu ^c   Imaoka, Takeshi ^c  

^a YOKOHAMA CITY UNIVERSITY   (Japan)

^b Asia Pacific Statistical Science Japan Science and Regulatory Affairs LRLMDU Japan Eli Lilly Japan KK   (Japan)

^c Medical Science Lilly Research Laboratories Development Center of Excellence Japan Eli Lilly Japan KK   (Japan)

Author keywords

Dose response; Dulaglutide; Japanese; Type 2 diabetes mellitus

Indexed keywords

AMYLASE; DULAGLUTIDE; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; GLUCOSE; HEMOGLOBIN A1C; ORAL ANTIDIABETIC AGENT; PLACEBO; TRIACYLGLYCEROL; TRIACYLGLYCEROL LIPASE; ANTIDIABETIC AGENT; GLUCAGON LIKE PEPTIDE; GLUCAGON RECEPTOR; GLUCAGON-LIKE PEPTIDE-1 RECEPTOR; GLUCOSE BLOOD LEVEL; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT;

ACUTE PANCREATITIS; ADULT; ALLERGY; ARTICLE; ASYMPTOMATIC HYPOGLYCEMIA; BELL PALSY; CONSTIPATION; CONTROLLED STUDY; DIABETIC PATIENT; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DIET RESTRICTION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ECG ABNORMALITY; EXERCISE; FEMALE; GASTROINTESTINAL DISEASE; GASTROINTESTINAL SYMPTOM; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEADACHE; HUMAN; HYPOGLYCEMIA; INJECTION SITE REACTION; JAPAN; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MONOTHERAPY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREAS CARCINOMA; PARALLEL DESIGN; PERIPHERAL VASCULAR DISEASE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SELF MONITORING; SINGLE DRUG DOSE; SYSTOLIC BLOOD PRESSURE; TRIACYLGLYCEROL BLOOD LEVEL; UNSPECIFIED SIDE EFFECT; UPPER ABDOMINAL PAIN; VITAL SIGN; AGONISTS; ANALOGS AND DERIVATIVES; ANALYSIS; BLOOD; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION; MULTICENTER STUDY; TREATMENT OUTCOME;

ADULT; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLUCAGON-LIKE PEPTIDES; HUMANS; HYPOGLYCEMIC AGENTS; IMMUNOGLOBULIN FC FRAGMENTS; MALE; MIDDLE AGED; RECEPTORS, GLUCAGON; RECOMBINANT FUSION PROTEINS; TREATMENT OUTCOME;

EID: 84908331441     PISSN: 09188959     EISSN: 13484540     Source Type: Journal    
DOI: 10.1507/endocrj.EJ14-0147     Document Type: Article

References (30)

1. Garber AJ (2011) Incretin therapy present and future. Rev Diabet Stud 8: 307-322.
2. Garber AJ (2011) Long-acting glucagon-like peptide 1 receptor agonists: a review of their efficacy and tolerability. Diabetes Care 34: S279-S284.
3. Combes J, Borot S, Mougel F, Penfornis A (2011) Thepotential role of glucagon-like peptide-1 or its analogues in enhancing glycaemic control in critically ill adult patients. Diabetes Obes Metab 13: 118-129.
4. Fineman MS, Cirincione BB, Maggs D, Diamant M (2012) GLP-1 based therapies: differential effects on fasting and postprandial glucose. Diabetes Obes Metab 14: 675-688.
5. Gallwitz B (2011) Glucagon-like peptide-1 analogues for Type 2 diabetes mellitus: current and emerging agents. Drugs 71: 1675-1688.
6. Garber AJ (2012) Novel GLP-1 receptor agonists for diabetes. Expert Opin Investig Drugs 21: 45-57.
7. Madsbad S, Kielgast U, Asmar M, Deacon CF, Torekov SS, et al. (2011) An overview of once-weekly glucagonlike peptide-1 receptor agonists available efficacy and safety data and perspectives for the future. Diabetes Obes Metab 13: 394-407.
8. Glaesner W, Vick AM, Millican R, Ellis B, Tschang SH, et al. (2010) Engineering and characterization of the long-acting glucagonlike peptide-1 analogue LY2189265, an Fc fusion protein. Diabetes Metab Res Rev 26: 287-296.
9. Wallace TM, Levy JC, Matthews DR (2004) Use and abuse of HOMA modeling. Diabetes Care 27: 1487-1495.
10. The National Institute for Health and Clinical Excellence (2009) Type 2 diabetes: the management of type 2 diabetes. NICE clinical guideline 87. London: Royal College of Physicians http://www.nice.org.uk/ nicemedia/pdf/CG87NICEGuideline.pdf. Accessed on: December 5, 2013.
11. American Diabetes Association (2009) Standards of medical care in diabetes 2009. Diabetes Care 32:S13-S61.
12. Barrington P, Chien JY, Showalter HD, Schneck K, Cui S, et al. (2011) A 5-week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, longacting glucagon-like peptide-1 analogue, in patients with type 2 diabetes. Diabetes Obes Metab 13: 426-433.
13. Grunberger G, Chang A, Garcia Soria G, Botros FT, Bsharat R, et al. (2012) Monotherapy with the onceweekly GLP-1 analogue dulaglutide for 12 weeks in patients with Type 2 diabetes: dose-dependent effects on glycaemic control in a randomized, double-blind, placebo-controlled study. Diabet Med 29: 1260-1267.
14. Barrington P, Chien JY, Tibaldi F, Showalter HD, Schneck K, et al. (2011) LY2189265, a long-acting glucagon- like peptide-1 analogue, showed a dose-dependent effect on insulin secretion in healthy subjects. Diabetes Obes Metab 13: 434-438.
15. Umpierrez GE, Blevins T, Rosenstock J, Cheng C, Anderson JH, et al.; EGO Study Group (2011) The effects of LY2189265, a long-acting glucagon-like peptide- 1 analogue, in a randomized, placebo-controlled, double-blind study of overweight/obese patients withtype 2 diabetes: the EGO study. Diabetes Obes Metab 13: 418-425.
16. Seino Y, Rasmussen MF, Zdravkovic M, Kaku K (2008) Dose-dependent improvement in glycemia with oncedaily liraglutide without hypoglycemia or weight gain: A double-blind, randomized, controlled trial in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract 81: 161-168.
17. Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW (2012) Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med 124:21-32.
18. Yabe D, Seino Y (2011) Liraglutide in adults with type 2 diabetes: global perspective on safety, efficacy and patient preference. Clin Med Insights Endocrinol Diabetes 4: 47-62.
19. Fujimoto WY, Boyko EJ, Hayashi T, Kahn SE, Leonetti DL, et al. (2012) Risk factors for type 2 diabetes: lessons learned from Japanese Americans in Seattle. J Diabetes Investig 3: 212-224.
20. Hirose T, Kawamori R (2005) Diabetes in Japan. Curr Diab Rep 5: 226-229.
21. Ratner RE, Rosenstock J, Boka G; DRI6012 Study Investigators (2010) Dose-dependent effects of the once-daily GLP-1 receptor agonist lixisenatide in patients with Type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebocontrolled trial. Diabet Med 27: 1024-1032.
22. Kadowaki T, Namba M, Yamamura A, Sowa H, Wolka AM, et al. (2009) Exenatide exhibits dose-dependent effects on glycemic control over 12 weeks in Japanese patients with suboptimally controlled type 2 diabetes. Endocr J 56: 415-424.
23. Inagaki N, Atsumi Y, Oura T, Saito H, Imaoka T (2012) Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, openlabel, parallel-group, multicenter, noninferiority study. Clin Ther 34: 1892-1908.
24. Ji L, Onishi Y, Ahn CW, Agarwal P, Chou CW, et al. (2013) Efficacy and safety of exenatide once-weekly vs exenatide twice-daily in Asian patients with Type 2 diabetes mellitus. J Diabetes Investig 4: 53-61.
25. Seino Y, Min KW, Niemoeller E, Takami A; EFC10887 GETGOAL-L Asia Study Investigators (2012) Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab 14: 910-917.
26. Egan AG, Blind E, Dunder K, de Graeff PA, Hummer BT, et al. (2014) Pancreatic safety of incretin-based drugs--FDA and EMA assessment. N Engl J Med 370: 794-797.
27. Alves C, Batel-Marques F, Macedo AF (2012) A metaanalysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract 98: 271-284.
28. Funch D, Gydesen H, Tornøe K, Major-Pedersen A, Chan KA (2014) A prospective, claims-based assessment of the risk of pancreatitis and pancreatic cancer with liraglutide compared to other antidiabetic drugs. Diabetes Obes Metab 16: 273-275.
29. Monami M, Dicembrini I, Nardini C, Fiordelli I, Mannucci E (2014) Glucagon-like peptide-1 receptor agonists and pancreatitis: a meta-analysis of randomized clinical trials. Diabetes Res Clin Pract 103: 269-275.
30. Li L, Shen J, Bala MM, Busse JW, Ebrahim S, et al. (2014) Incretin treatment and risk of pancreatitis in patients with type 2 diabetes mellitus: systematic review and meta-analysis of randomised and non-randomised studies. BMJ 348: g2366