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, placebo-controlled trial

Diabetic Medicine

Volumn 27, Issue 9, 2010, Pages 1024-1032

  Ratner, R E ^a   Rosenstock, J ^b   Boka, G ^c  

^a GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b DALLAS DIABETES AND ENDOCRINE CENTER AT MEDICAL CITY   (United States)

^c SANOFI   (France)

Author keywords

glucagon like peptide 1 receptor agonist; glycaemic control; lixisenatide; Type 2 diabetes

Indexed keywords

ANTIDIABETIC AGENT; AVE 0010; GLUCOSE; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C; LIXISENATIDE; METFORMIN; PLACEBO; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG ACTIVITY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FEMALE; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; HYPOGLYCEMIA; LIP SWELLING; MAJOR CLINICAL STUDY; MALE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SWELLING; TONGUE SWELLING; TREATMENT OUTCOME; URTICARIA; VOMITING; WEIGHT CHANGE;

ADULT; AGED; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG RESISTANCE; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; MALE; METFORMIN; MIDDLE AGED; PEPTIDES; PLACEBOS; RECEPTORS, GLUCAGON;

EID: 77955887980     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/j.1464-5491.2010.03020.x     Document Type: Article

References (25)

1. American Diabetes Association. Standards for diabetes care - 2008. Diabetes Care 2008 31 : S12 S54.
2. International Diabetes Federation. Global Guideline for Type 2 Diabetes, 2005. Available at http://www.idf.org/home/index.cfm?node=1457 Last accessed 29 January 2009.
3. Alvarez Guisasola F, Mavros P, Nocea G, Alemao E, Alexander CM, Yin D. Glycaemic control among patients with type 2 diabetes mellitus in seven European countries: findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) study. Diabetes Obes Metab 2008 10 (Suppl 1 8 15.
4. Drucker DJ. Enhancing incretin action for the treatment of type 2 diabetes. Diabetes Care 2003 26 : 2929 2940.
5. Holst JJ, Deacon CF, Vilsbøll T, Krarup T, Madsbad S. Glucagon-like peptide-1, glucose homeostasis and diabetes. Trends Mol Med 2008 14 : 161 168.
6. Nauck MA, Heimesaat MM, Behle K, Holst JJ, Nauck MS, Schmiegel WH et al. Effects of glucagon-like peptide 1 on counterregulatory hormone responses, cognitive functions, and insulin secretion during hyperinsulinemic, stepped hypoglycemic clamp experiments in healthy volunteers. J Clin Endocrinol Metab 2002 87 : 1239 1246.
7. Stoffers DA, Kieffer TJ, Hussain MA, Drucker DJ, Bonner-Weir S, Habener JF et al. Insulinotropic glucagon-like peptide 1 agonists stimulate expression of homeodomain protein IDX-1 and increase islet size in mouse pancreas. Diabetes 2000 49 : 741 748.
8. Li Y, Hansotia T, Yusta B, Ris F, Halban PA, Drucker DJ. Glucagon-like peptide-1 receptor signaling modulates beta cell apoptosis. J Biol Chem 2003 278 : 471 478.
9. Thorkildsen C, Neve S, Larsen BD, Meier E, Petersen JS. Glucagon-like peptide 1 receptor agonist ZP10A increases insulin mRNA expression and prevents diabetic progression in db/db mice. J Pharmacol Exp Ther 2003 307 : 490 496.
10. Brubaker PL, Drucker DJ. Minireview: glucagon-like peptides regulate cell proliferation and apoptosis in the pancreas, gut, and central nervous system. Endocrinology 2004 145 : 2653 2659.
11. Tews D, Werner U, Eckel J. Enhanced protection against cytokine- and fatty acid-induced apoptosis in pancreatic beta cells by combined treatment with glucagon-like peptide-1 receptor agonists and insulin analogues. Horm Metab Res 2008 40 : 172 180.
12. Werner U, Vandewalle B, Kerr Conte J, Pattou F, Pruniaux M-P, Herling AW. The GLP-1 receptor agonist AVE0010 improves GSIS, prevents lipotoxicity-induced insulin depletion and preserves beta-cell function in human pancreatic islets [abstract]. Diabetes 2008 57 (Suppl 1 A3 A4.
13. Distiller LA, Ruus P, on behalf of the ACT6011 Study Group. Pharmacokinetics and pharmacodynamics of a new GLP-1 agonist AVE0010 in type 2 diabetes patients [abstract]. Diabetes 2008 57 (Suppl 1 A154 A155.
14. Hoelzel W, Weykamp C, Jeppsson JO, Miedema K, Barr JR, Goodall I et al. IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan, and Sweden: a method-comparison study. Clin Chem 2004 50 : 166 174.
15. Sacks DB, ADA/EASD/IDF Working Group of the HbA1c Assay. Global harmonization of hemoglobin A1c. Clin Chem 2005 51 : 681 683.
16. Madsbad S, Schmitz O, Ranstam J, Jakobsen G, Matthews DR, NN2211-1310 International Study Group. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial. Diabetes Care 2007 27 : 1335 1342.
17. Feinglos MN, Saad MF, Pi-Sunyer FX, An B, Santiago O, Liraglutide Dose-Response Study Group. Effects of liraglutide (NN2211), a long-acting GLP-1 analogue, on glycaemic control and bodyweight in subjects with type 2 diabetes. Diabet Med 2005 22 : 1016 1023.
18. Poon T, Nelson P, Shen L, Mihm M, Taylor K, Fineman M et al. Exenatide improves glycemic control and reduces body weight in subjects with type 2 diabetes: a dose-ranging study. Diabetes Technol Ther 2005 7 : 467 477.
19. Vilsbøll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Courrèges JP et al. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes. Diabetes Care 2007 30 : 1608 1610.
20. Ong KL, Cheung BM, Wong LY, Wat NM, Tan KC, Lam KS. Prevalence, treatment, and control of diagnosed diabetes in the U.S. National Health and Nutrition Examination Survey 1999-2004. Ann Epidemiol 2008 18 : 222 229.
21. Nilsson PM. Is weight loss beneficial for reduction of morbidity and mortality? What is the controversy about? Diabetes Care 2008 31 : S278 S283.
22. The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008 358 : 2545 2559.
23. DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD. 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.
24. Buse JB, Henry RR, Han J, Kim DD, Fineman MS, Baron AD, Exenatide-113 Clinical Study Group. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care 2004 27 : 2628 2635.
25. Kendall DM, Riddle MC, Rosenstock J, Zhuang D, Kim DD, Fineman MS et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care 2005 28 : 1083 1091.