Efficacy and safety of taspoglutide versus sitagliptin for type 2 diabetes mellitus (T-Emerge 4 Trial)

Diabetes Therapy

Volumn 3, Issue 1, 2012, Pages 1-19

  Bergenstal, Richard M ^a   Forti, Adriana ^b   Chiasson, Jean Louis ^c   Woloschak, Michael ^d   Boldrin, Mark ^d   Balena, Raffaella ^e  

^a INTERNATIONAL DIABETES CENTER   (United States)

^b FEDERAL UNIVERSITY OF CEARÁ   (Brazil)

^c CENTRE HOSPITALIER DE L UNIVERSITÉ DE MONTRÉAL   (Canada)

^d HOFFMANN LA ROCHE INC   (United States)

^e F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Dipeptidyl peptidase 4; Glucagonlike peptide 1; Glycemic control; Metformin; Sitagliptin; Taspoglutide; Type 2 diabetes mellitus; Weight loss

Indexed keywords

DRUG ANTIBODY; GLUCOSE; HEMOGLOBIN A1C; PLACEBO; SITAGLIPTIN; TASPOGLUTIDE;

ACUTE KIDNEY FAILURE; ADULT; AGED; ARTHRALGIA; ARTICLE; CLINICAL ASSESSMENT; CONSTIPATION; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DIABETES CONTROL; DIARRHEA; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; ENTERITIS; FEMALE; GASTRITIS; GASTROESOPHAGEAL REFLUX; GASTROINTESTINAL SYMPTOM; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEAD INJURY; HEADACHE; HEART ARREST; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERTENSION; HYPOGLYCEMIA; INFLUENZA; INJECTION SITE ERYTHEMA; INJECTION SITE MASS; INJECTION SITE NODULE; INJECTION SITE PRURITUS; LACTIC ACIDOSIS; LONG TERM CARE; MAJOR CLINICAL STUDY; MALAISE; MALE; MULTICENTER STUDY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SHORT COURSE THERAPY; TREATMENT DURATION; TREATMENT OUTCOME; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VOMITING; WEIGHT REDUCTION;

EID: 84871126011     PISSN: 18696953     EISSN: 18696961     Source Type: Journal    
DOI: 10.1007/s13300-012-0013-8     Document Type: Article

References (23)

1. Krentz AJ, Bailey CJ. Oral antidiabetic agents: current role in type 2 diabetes mellitus. Drugs. 2005;65:385-411.
2. Aaboe K, Krarup T, Madsbad S, Holst JJ. GLP-1: physiological effects and potential therapeutic applications. Diabetes Obes Metab. 2008;10: 994-1003.
3. Deacon CF. Incretin-based treatment of type 2 diabetes: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors. Diabetes Obes Metab. 2007;9(Suppl. 1):23-31.
4. Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA. 2007;298: 194-206.
5. Nauck M, Frid A, Hermansen K, et al. LEAD-2 Study Group. 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.
6. Buse JB, Rosenstock J, Sesti G, LEAD-6 Study Group, et al. 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.
7. Buse JB, Drucker DJ, Taylor KL, DURATION-1 Study Group, et al. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care. 2010;33: 1255-61.
8. Bergenstal RM, Wysham C, Macconell L, DURATION-2 Study Group, 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;376:431-9.
9. Charbonnel B, Karasik A, Liu J, Wu M, Meininger G. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006;29:2638-43.
10. Raz I, Chen Y, Wu M, et al. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008;24:537-50.
11. Taskinen MR, Rosenstock J, Tamminen I, et al. Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab. 2011;13:65-74.
12. Kapitza C, Heise T, Birman P, Jallet K, Ramis J, Balena R. Pharmacokinetic and pharmacodynamic properties of taspoglutide, a once-weekly, human GLP-1 analogue, after single-dose administration in patients with type 2 diabetes. Diabet Med. 2009; 26:1156-64.
13. Nauck MA, Ratner RE, Kapitza C, Berria R, Boldrin M, Balena R. Treatment with the human onceweekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone: a double-blind placebocontrolled study. Diabetes Care. 2009;32:1237-43.
14. Ratner R, Nauck M, Kapitza C, Asnaghi V, Boldrin M, Balena R. Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebocontrolled study. Diabetic Med. 2010;27:556-62.
15. Pratley RE, Nauck M, Bailey T, 1860-LIRA-DPP-4 Study Group, et al. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet. 2010;375:1447-56.
16. 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;28:1092-100.
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;375:2234-43.
18. Drucker DJ, Buse JB, Taylor K, DURATION-1 Study Group, et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008;372:1240-50.
19. Aroda VR, Ratner R. The safety and tolerability of GLP-1 receptor agonists in the treatment of type 2 diabetes: a review. Diabetes Metab Res Rev. 2011;27:528-42.
20. Fineman MS, Mace KF, Diamant M, et al. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012;14:546-54.
21. Marre M, Shaw J, Brandle M, LEAD-1 SU Study Group, et al. 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;26:268-78.
22. Zinman B, Gerich J, Buse JB, LEAD-4 Study Investigators, et al. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met + TZD). Diabetes Care. 2009;32: 1224-30.
23. Kim D, MacConell L, Zhuang D, et al. Effects of once-weekly dosing of a long-acting release formulation of exenatide on glucose control and body weight in subjects with type 2 diabetes. Diabetes Care. 2007;30:1487-93.