Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): A 26-week double-blind study

Diabetes Care

Volumn 35, Issue 2, 2012, Pages 252-258

  Russell Jones, David ^a   Cuddihy, Robert M ^b   Hanefeld, Markolf ^c   Kumar, Ajay ^d   González, Jose G ^e   Chan, Melanie ^f   Wolka, Anne M ^f   Boardman, Marilyn K ^f  

^a UNIVERSITY OF SURREY   (United Kingdom)

^b INTERNATIONAL DIABETES CENTER   (United States)

^c DRESDEN UNIVERSITY OF TECHNOLOGY   (Germany)

^d Diabetes Care and Research Center   (India)

^e HOSPITAL UNIVERSITARIO DR JOSÉ ELEUTERIO GONZÁLEZ   (Mexico)

^f ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EXENDIN 4; GLUCOSE; HEMOGLOBIN A1C; METFORMIN; PIOGLITAZONE; PLACEBO; SITAGLIPTIN;

ADULT; AGED; ARTHRALGIA; ARTICLE; BACKACHE; BODY WEIGHT; CAUCASIAN; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DISEASE DURATION; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEADACHE; HUMAN; HYPERTENSION; HYPOGLYCEMIA; INJECTION SITE NODULE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PERIPHERAL EDEMA; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS;

DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; MALE; METFORMIN; MIDDLE AGED; PEPTIDES; PYRAZINES; THIAZOLIDINEDIONES; TREATMENT OUTCOME; TRIAZOLES; VENOMS;

EID: 84859013614     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc11-1107     Document Type: Article

References (25)

1. Nathan DM, Buse JB, Davidson MB, et al. Medical management ofhyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009;32:193-203
2. Schernthaner G, Matthews DR, Charbonnel B, Hanefeld M, Brunetti P; Quartet [corrected] Study Group. Efficacy and safety of pioglitazone versus metformin in patients with type 2 diabetes mellitus: a double-blind, randomized trial. J Clin Endocrinol Metab 2004;89:6068-6076 (Pubitemid 39628416)
3. Pavo I, Jermendy G, Varkonyi TT, et al. Effect of pioglitazone compared with metformin on glycemic control and indicators of insulin sensitivity in recently diagnosed patients with type 2 diabetes. J Clin Endocrinol Metab 2003;88:1637-1645 (Pubitemid 36623381)
4. Moretto TJ, Milton DR, Ridge TD, et al. Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther 2008;30:1448-1460
5. Aschner P, Katzeff HL, Guo H, et al. Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes. Diabetes Obes Metab 2010;12:252-261
6. Drucker DJ, Buse JB, Taylor K, et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet 2008;372:1240-1250
7. Blevins T, Pullman J, Malloy J, et al. DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab 2011;96:1301-1310
8. Hommel G. A stagewise rejective multiple test procedure based on a modified Bonferroni test. Biometrika 1988;75:383-386
9. Dmitrienko A, Molenberghs G, Chuang-Stein C, Offen W. Analysis of Clinical Trials Using SAS: A Practical Guide. Cary, NC, SAS Institute Inc, 2005
10. Bergenstal RM, Wysham C, Macconell L, et al. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet 2010;376:431-439
11. Tan MH, Johns D, Strand J, et al. Sustained effects of pioglitazone vs. glibenclamide on insulin sensitivity, glycaemic control, and lipid profiles in patients with type 2 diabetes. Diabet Med 2004;21:859-866 (Pubitemid 39036999)
12. Tan MH, Baksi A, Krahulec B, et al. Comparison of pioglitazone and gliclazide in sustaining glycemic control over 2 years in patients with type 2 diabetes. Diabetes Care 2005;28:544-550 (Pubitemid 40315311)
13. Rosenstock J, Kim SW, Baron MA, et al. Efficacy and tolerability ofinitial combination therapy with vildagliptin and pioglitazone compared with component monotherapy in patients with type 2 diabetes. Diabetes Obes Metab 2007;9:175-185 (Pubitemid 46206561)
14. Charbonnel BH, Matthews DR, Schernthaner G, Hanefeld M, Brunetti P; QUARTET Study Group. A long-term comparison of pioglitazone and gliclazide in patients with type 2 diabetes mellitus: a randomized, double-blind, parallel-group comparison trial. Diabet Med 2005;22:399-405 (Pubitemid 40516237)
15. DeFronzo RA, Okerson T, Viswanathan P, Guan X, Holcombe JH, MacConell L. Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: a randomized, cross-over study. Curr Med Res Opin 2008;24:2943-2952
16. Pratley RE, Nauck M, Bailey T, et al. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet 2010;375:1447-1456
17. Diamant M, Van Gaal L, Stranks S, et al. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet 2010;375:2234-2243
18. Schweizer A, Couturier A, Foley JE, Dejager S. Comparison between vildagliptin and metformin to sustain reductions in HbA(1c) over 1 year in drug-naïve patients with type 2 diabetes. Diabet Med 2007;24:955-961 (Pubitemid 47301637)
19. Johansen K. Efficacy of metformin in the treatment of NIDDM: meta-analysis. Diabetes Care 1999;22:33-37 (Pubitemid 29028295)
20. Jadzinsky M, Pfützner A, Paz-Pacheco E, et al. Saxagliptin given incombination with metformin as initial therapy improves glycemic control in patients with type 2 diabetes compared with either monotherapy: a randomized controlled trial. Diabetes Obes Metab 2009;11:611-622
21. Liutkus J, Rosas Guzman J, Norwood P, et al. A placebo-controlled trial of exenatide twice-daily added to thiazolidinediones alone or in combination with metformin. Diabetes Obes Metab 2010;12:1058-1065
22. Schweizer A, Dejager S, Bosi E. Comparison of vildagliptin and metformin monotherapy in elderly patients with type 2 diabetes: a 24-week, double-blind, randomized trial. Diabetes Obes Metab 2009;11:804-812
23. Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE; Sitagliptin 036 Study Group. Effect ofinitial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care 2007;30:1979-1987 (Pubitemid 47219404)
24. DeFronzo RA, Goodman AM; The Multicenter Metformin Study Group. Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. N Engl J Med 1995;333:541-549
25. Bunck MC, Cornér A, Eliasson B, et al. Effects of exenatide on measures of β-cell function after 3 years in metformin-treated patients with type 2 diabetes. Diabetes Care 2011;34:2041-2047