Dapagliflozin, metformin XR, or both: Initial pharmacotherapy for type 2 diabetes, a randomised controlled trial

International Journal of Clinical Practice

Volumn 66, Issue 5, 2012, Pages 446-456

  Henry, R R ^a   Murray, A V ^b   Marmolejo, M H ^c   Hennicken, D ^d   Ptaszynska, A ^d   List, J F ^d  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b PharmQuest   (United States)

^c Torre Medica Providencia   (Mexico)

^d BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DAPAGLIFLOZIN; GLUCOSE; HEMOGLOBIN A1C; METFORMIN; PLACEBO;

ADULT; AGED; ARTICLE; BALANITIS; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG FATALITY; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; FEMALE; GENITAL TRACT INFECTION; GLUCOSE BLOOD LEVEL; GLUCOSURIA; HEMATOCRIT; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; HYPOTENSION; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SYNCOPE; SYSTOLIC BLOOD PRESSURE; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; URIC ACID BLOOD LEVEL; URINARY TRACT INFECTION; VAGINA MYCOSIS; WEIGHT REDUCTION;

ADOLESCENT; ADULT; AGED; BLOOD GLUCOSE; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; FEMALE; GLUCOSIDES; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; MALE; METFORMIN; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84860218907     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/j.1742-1241.2012.02911.x     Document Type: Article

References (22)

1. Bailey CJ, Gross JL, Pieters A, et al., Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet 2010; 375: 2223-33.
2. Krentz AJ, Patel MB, Bailey CJ,. New drugs for type 2 diabetes mellitus: what is their place in therapy? Drugs 2008; 68: 2131-62.
3. Garber AJ, Duncan TG, Goodman AM, et al., Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial. Am J Med 1997; 103: 491-7. (Pubitemid 28018651)
4. Scarpello JH, Howlett HC,. Metformin therapy and clinical uses. Diab Vasc Dis Res 2008; 5: 157-67.
5. Fujioka K, Pans M, Joyal S,. Glycaemic control in patients with type 2 diabetes mellitus switched from twice-daily immediate-release metformin to a once-daily extended-release formulation. Clin Ther 2003; 25: 515-29. (Pubitemid 36286917)
6. Jabbour S, Ziring B,. Advantages of extended-release metformin in patients with type 2 diabetes mellitus. Postgrad Med 2011; 123: 15-23.
7. Nathan DM, Buse JB, Davidson MB, et al., Medical management of hyperglycaemia 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.
8. Zhang M, Tsiatis AA, Davidian M,. Improving efficiency of inferences in randomized clinical trials using auxiliary covariates. Biometrics 2008; 64: 707-15.
9. Tsiatis AA, Davidian M, Zhang M, Lu X,. Covariate adjustment for two-sample treatment comparisons in randomized clinical trials: a principled yet flexible approach. Stat Med 2008; 27: 4658-77.
10. Handelsman Y, Mechanick JI, Blonde L,. American Association of Clinical Endocrinologists medical guidelines for clinical practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract 2011; 17 (Suppl. 2): 1-53.
11. Canadian Diabetes Association. Clinical practice guidelines for the prevention and management of diabetes in Canada. Can J Diabetes 2008; 32: S1-215.
12. Holman RR, Paul SK, Bethel MA, et al., 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008; 359: 1577-89.
13. Goldstein BJ, Feinglos MN, Lunceford JK, et al., Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycaemic control in patients with type 2 diabetes. Diabetes Care 2007; 30: 1979-87. (Pubitemid 47219404)
14. Williams-Herman D, Johnson J, Teng R, et al., Efficacy and safety of sitagliptin and metformin as initial combination therapy and as monotherapy over 2 years in patients with type 2 diabetes. Diabetes Obes Metab 2010; 12: 442-51.
15. Jadzinsky M, Pfutzner A, Paz-Pacheco E, et al., Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy: a randomized controlled trial. Diabetes Obes Metab 2009; 11: 611-22.
16. Bosi E, Dotta F, Jia Y, Goodman M,. Vildagliptin plus metformin combination therapy provides superior glycaemic control to individual monotherapy in treatment-naive patients with type 2 diabetes mellitus. Diabetes Obes Metab 2009; 11: 506-15.
17. Rosenstock J, Rood J, Cobitz A, et al., Initial treatment with rosiglitazone/metformin fixed-dose combination therapy compared with monotherapy with either rosiglitazone or metformin in patients with uncontrolled type 2 diabetes. Diabetes Obes Metab 2006; 8: 650-60. (Pubitemid 44515562)
18. Schwarz SL, Gerich JE, Marcellari A, et al., Nateglinide, alone or in combination with metformin, is effective and well tolerated in treatment-naive elderly patients with type 2 diabetes. Diabetes Obes Metab 2008; 10: 652-60. (Pubitemid 352044295)
19. Rosenstock J, Fonseca VA, Garvey WT, et al., Initial combination therapy with metformin and colesevelam for achievement of glycaemic and lipid goals in early type 2 diabetes. Endocr Pract 2010; 16: 629-40.
20. Reasner C, Olansky L, Seck TL, et al., The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab 2011; 13: 644-52.
21. Garber AJ, Larsen J, Schneider SH, et al., Simultaneous glyburide/metformin therapy is superior to component monotherapy as an initial pharmacological treatment for type 2 diabetes. Diabetes Obes Metab 2002; 4: 201-8. (Pubitemid 34567677)
22. Ferrannini E, Ramos SJ, Salsali A, et al., Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycaemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care 2010; 33: 2217-24.