HARMONY 3: 104-week randomized, double-blind, placebo- and active-controlled trial assessing the efficacy and safety of albiglutide compared with placebo, sitagliptin, and glimepiride in patients with type 2 diabetes taking metformin

Diabetes Care

Volumn 37, Issue 8, 2014, Pages 2141-2148

  Ahrén, Bo ^a   Johnson, Susan L ^b   Stewart, Murray ^b   Cirkel, Deborah T ^c   Yang, Fred ^b   Perry, Caroline ^b   Feinglos, Mark N ^d  

^a LUND UNIVERSITY   (Sweden)

^b GLAXOSMITHKLINE   (United States)

^c GLAXOSMITHKLINE   (United Kingdom)

^d DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALBIGLUTIDE; GLIMEPIRIDE; GLUCOSE; HEMOGLOBIN A1C; LIPID; METFORMIN; PLACEBO; SITAGLIPTIN; ANTIDIABETIC AGENT; GLUCAGON LIKE PEPTIDE 1; GLYCOSYLATED HEMOGLOBIN; PYRAZINE DERIVATIVE; RGLP-1 PROTEIN; SULFONYLUREA DERIVATIVE; TRIAZOLE DERIVATIVE;

ADULT; ALLERGIC REACTION; ANGIONEUROTIC EDEMA; ARTICLE; COMPARATIVE STUDY; CONTROLLED STUDY; COUGHING; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GLUCOSE BLOOD LEVEL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOGLYCEMIA; IMMUNOGENICITY; INJECTION SITE REACTION; LIPID BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREATITIS; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; STRUCTURE ACTIVITY RELATION; SYSTOLIC BLOOD PRESSURE; THYROID CARCINOMA; THYROID FOLLICULAR CARCINOMA; THYROID PAPILLARY CARCINOMA; UPPER RESPIRATORY TRACT INFECTION; VOMITING; WEIGHT CHANGE; WEIGHT GAIN; WEIGHT REDUCTION; AGED; ANALOGS AND DERIVATIVES; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; DRUG COMBINATION; MIDDLE AGED; TREATMENT OUTCOME;

AGED; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GLUCAGON-LIKE PEPTIDE 1; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIC AGENTS; MALE; METFORMIN; MIDDLE AGED; PYRAZINES; SULFONYLUREA COMPOUNDS; TREATMENT OUTCOME; TRIAZOLES;

EID: 84904963065     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc14-0024     Document Type: Article

References (24)

1. Setji T, Feinglos M. Albiglutide: clinical overview of a long-acting GLP-1 receptor agonist in the treatment of type 2 diabetes. Expert Rev Endocrinol Metab 2013; 8: 229-238
2. Ong KL, Cheung BM, Wong L.Y., 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
3. Saaddine JB, Cadwell B, Gregg E.W., et al. Improvements in diabetes processes of care and intermediate outcomes: United States, 1988-2002. Ann Intern Med 2006; 144: 465-474
4. American Diabetes Association. Standards of medical care in diabetesd2009. Diabetes Care 2009; 32(Suppl 1): S13-S61
5. Aikens JE, Piette JD Longitudinal association between medication adherence and glycaemic control in Type 2 diabetes. Diabet Med 2013; 30: 338-344
6. Cramer JA. A systematic review of adherence with medications for diabetes. Diabetes Care 2004; 27: 1218-1224
7. Bailey CJ, Kodack M. Patient adherence to medication requirements for therapy of type 2 diabetes. Int J Clin Pract 2011; 65: 314-322
8. Davies MJ, Gagliardino JJ, Gray L.J., Khunti K., Mohan V, Hughes R. Real-world factors affecting adherence toinsulin therapy in patients with Type 1 or Type 2 diabetes mellitus: a systematic review. Diabet Med 2013; 30: 512-524
9. DiMatteo MR. Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care 2004; 42: 200-209
10. Inzucchi SE, Bergenstal RM, Buse J.B., et al; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012; 35: 1364-1379
11. NIH begins recruitment for long-term study of diabetes drug efficacy [press release online], 2013. Bethesda, MD, National Institutes of Health. Available from http://www.nih.gov/news/health/jun2013/niddk-03.htm. Accessed 20 August 2013
12. Scheen AJ. DPP-4 inhibitors in the management of type 2 diabetes: a critical review of head-to-head trials. Diabetes Metab 2012; 38: 89-101
13. St Onge E.L., Miller SA Albiglutide: a new GLP-1 analog for the treatment of type 2 diabetes. Expert Opin Biol Ther 2010; 10: 801-806
14. American Diabetes Association. Standards of medical care in diabetesd2014. Diabetes Care 2014; 37(Suppl 1): S14-S80
15. Matthews JE, Stewart MW, De Boever EH, et al. Pharmacodynamics, pharmacokinetics, safety and tolerability of albiglutide, a longacting glucagon-like peptide-1 mimetic, in patients with type 2 diabetes. J Clin Endocrinol Metab 2008; 93: 4810-4817
16. Rosenstock J, Reusch J, Bush M., Yang F, Stewart M; Albiglutide Study Group. Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing. Diabetes Care 2009; 32: 1880-1886
17. Rosenstock J, Fonseca V, Gross J.L., et al. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist versus thrice daily prandial insulin lispro. Lancet. In press
18. Pratley RE, Nauck MA, Barnett A.H., et al; HARMONY 7 Study Group. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral agents (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol 2014; 2: 289-297
19. Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 2005; 28: 1245-1249
20. Bergenstal RM, Wysham C, Macconell L., et al; DURATION-2 Study Group. 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
21. 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 indiabetes)-2 study. Diabetes Care 2009; 32: 84-90
22. Charbonnel B, Steinberg H, Eymard E., et al. Efficacy and safety over 26 weeks of an oral treatment strategy including sitagliptin compared with an injectable treatment strategy with liraglutide in patients with type 2 diabetes mellitus inadequately controlled on metformin: a randomised clinical trial. Diabetologia 2013; 56: 1503-1511
23. Victoza (liraglutide [rDNA origin] injection) [prescribing information]. Princeton, NJ, Novo Nordisk Inc., April 2013
24. Byetta (exenatide) injection [prescribing information]. San Diego, CA, Amylin Pharmaceuticals, Inc., February 2013