Study to determine the durability of glycaemic control with early treatment with a vildagliptin-metformin combination regimen vs. standard-of-care metformin monotherapy-the VERIFY trial: A randomized double-blind trial

Diabetic Medicine

Volumn 31, Issue 10, 2014, Pages 1178-1184

  Del Prato, S ^a   Foley, J E ^b   Kothny, W ^b   Kozlovski, P ^b   Stumvoll, M ^c   Paldanius P M ^b   Matthews, David R ^d,e,f  

^a UNIVERSITY OF PISA   (Italy)

^b NOVARTIS PHARMA AG   (Switzerland)

^c UNIVERSITY OF LEIPZIG   (Germany)

^d UNIVERSITY OF OXFORD   (United Kingdom)

^e Oxford Centre for Diabetes Endocrinology and Metabolism ^*  (United Kingdom)

^f UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN; METFORMIN; PLACEBO; VILDAGLIPTIN; ADAMANTANE; ANTIDIABETIC AGENT; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; NITRILE; PYRROLIDINE DERIVATIVE;

ADD ON THERAPY; ADULT; AGED; ARTICLE; CELL FUNCTION; CLINICAL ASSESSMENT; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFECT; DRUG EFFICACY; EARLY INTERVENTION; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEALTH STATUS; HEMOGLOBIN BLOOD LEVEL; HUMAN; INSULIN RESISTANCE; MAJOR CLINICAL STUDY; MAXIMUM TOLERATED DOSE; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREAS ISLET BETA CELL; PROPORTIONAL HAZARDS MODEL; RANDOMIZED CONTROLLED TRIAL; REGRESSION ANALYSIS; TREATMENT FAILURE; ADOLESCENT; ANALOGS AND DERIVATIVES; BLOOD; BODY MASS; CLINICAL TRIAL; COMPLICATION; DIABETES MELLITUS, TYPE 2; DRUG COMBINATION; HYPERGLYCEMIA; INTENTION TO TREAT ANALYSIS; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; OBESITY; YOUNG ADULT;

ADAMANTANE; ADOLESCENT; ADULT; AGED; BODY MASS INDEX; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIC AGENTS; INTENTION TO TREAT ANALYSIS; METFORMIN; MIDDLE AGED; NITRILES; OBESITY; OVERWEIGHT; PYRROLIDINES; RESEARCH DESIGN; YOUNG ADULT;

EID: 84917736995     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/dme.12508     Document Type: Article

References (19)

1. Matthews DR, Dejager S, Ahren B, Fonseca V, Ferrannini E, Couturier A et al. Vildagliptin add-on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: results from a 2-year study. Diabetes Obes Metab 2010; 12: 780-789.
2. Ahren B. Clinical results of treating type 2 diabetic patients with sitagliptin, vildagliptin or saxagliptin-diabetes control and potential adverse events. Best Pract Res Clin Endocrinol Metab 2009; 23: 487-498.
3. Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP et al. ADOPT Study Group: Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006; 355: 2427-2443.
4. Kahn SE, Lachin JM, Zinman B, Haffner SM, Aftring RP, Paul G et al. Effects of rosiglitazone, glyburide, and metformin on beta-cell function and insulin sensitivity in ADOPT. Diabetes 2011; 60: 1552-1560.
5. Scherbaum WA, Schweizer A, Mari A, Nilsson PM, Lalanne G, Wang Y et al. Evidence that vildagliptin attenuates deterioration of glycaemic control during 2-year treatment of patients with type 2 diabetes and mild hyperglycaemia. Diabetes Obes Metab 2008; 10: 1114-1124.
6. Pratley RE, Schweizer A, Rosenstock J, Foley JE, Banerji MA, Pi-Sunyer FX et al. Robust improvements in fasting and prandial measures of beta-cell function with vildagliptin in drug-naive patients: analysis of pooled vildagliptin monotherapy database. Diabetes Obes Metab 2008; 10: 931-938.
7. Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 1985; 28: 412-419.
8. Wallace TM, Matthews DR. Coefficient of failure: a methodology for examining longitudinal beta-cell function in Type 2 diabetes. Diabet Med 2002; 19: 465-469.
9. Hochberg Y, Benjamini Y. More powerful procedures for multiple significance testing. Stat Med 1990; 9: 811-818.
10. Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006; 355: 2427-2443.
11. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M et al. 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.
12. Defronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes 2009; 58: 773-795.
13. IDF. Global Guideline for the Treatment of Type 2 Diabetes. International Diabetes Federation, 2012. Available at: http://www. idf.org/sites/default/files/IDF T2DM Guideline.pdf Last accessed 11 June 2014.
14. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M et al. Management of hyperglycaemia 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). Diabetologia 2012; 55: 1577-1596.
15. Ferrannini E, Fonseca V, Zinman B, Matthews D, Ahren B, Byiers S et al. Fifty-two-week efficacy and safety of vildagliptin vs. glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy. Diabetes Obes Metab 2009; 11: 157-166.
16. Goke B, Hershon K, Kerr D, Calle Pascual A, Schweizer A, Foley J et al. Efficacy and safety of vildagliptin monotherapy during 2-year treatment of drug-naive patients with Type 2 diabetes: comparison with metformin. Horm Metab Res 2008; 40: 892-895.
17. White WB, Pratley R, Fleck P, Munsaka M, Hisada M, Wilson C et al. Cardiovascular safety of the dipetidyl peptidase-4 inhibitor alogliptin in type 2 diabetes mellitus. Diabetes Obes Metab 2013; 15: 668-673.
18. Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B et al. Saxagliptin and cardiovascular outcomes in patients with Type 2 diabetes mellitus. N Engl J Med 2013; 369: 1317-1326.
19. Sjolie AK, Klein R, Porta M, Orchard T, Fuller J, Parving HH et al. Retinal microaneurysm count predicts progression and regression of diabetic retinopathy. Post-hoc results from the DIRECT Programme. Diabet Med 2011; 28: 345-351.