Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial - PubMed (original) (raw)

Clinical Trial

. 2013 Sep;36(9):2508-15.

doi: 10.2337/dc12-2491. Epub 2013 Apr 5.

Affiliations

Clinical Trial

Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial

Guntram Schernthaner et al. Diabetes Care. 2013 Sep.

Erratum in

Abstract

Objective: To evaluate the efficacy and safety of canagliflozin, a sodium glucose cotransporter 2 inhibitor, compared with sitagliptin in subjects with type 2 diabetes inadequately controlled with metformin plus sulfonylurea.

Research design and methods: In this 52-week, randomized, double-blind, active-controlled, phase 3 study, subjects using stable metformin plus sulfonylurea (N = 755) received canagliflozin 300 mg or sitagliptin 100 mg daily. Primary end point was change from baseline in A1C at 52 weeks. Secondary end points included change in fasting plasma glucose (FPG) and systolic blood pressure (BP), and percent change in body weight, triglycerides, and HDL cholesterol. Safety was assessed based on adverse event (AE) reports.

Results: At 52 weeks, canagliflozin 300 mg demonstrated noninferiority and, in a subsequent assessment, showed superiority to sitagliptin 100 mg in reducing A1C (-1.03% [-11.3 mmol/mol] and -0.66% [-7.2 mmol/mol], respectively; least squares mean difference between groups, -0.37% [95% CI, -0.50 to -0.25] or -4.0 mmol/mol [-5.5 to -2.7]). Greater reductions in FPG, body weight, and systolic BP were observed with canagliflozin versus sitagliptin (P < 0.001). Overall AE rates were similar with canagliflozin (76.7%) and sitagliptin (77.5%); incidence of serious AEs and AE-related discontinuations was low for both groups. Higher incidences of genital mycotic infections and osmotic diuresis-related AEs were observed with canagliflozin, which led to one discontinuation. Hypoglycemia rates were similar in both groups.

Conclusions: Findings suggest that canagliflozin may be a new therapeutic tool providing better improvement in glycemic control and body weight reduction than sitagliptin, but with increased genital infections in subjects with type 2 diabetes using metformin plus sulfonylurea.

Trial registration: ClinicalTrials.gov NCT01137812.

PubMed Disclaimer

Figures

Figure 1

Figure 1

Study flow diagram. SITA, sitagliptin; CANA, canagliflozin.

Figure 2

Figure 2

Changes in efficacy parameters (last observation carried forward [LOCF]). Change in A1C (A), mean A1C over time (B), change in FPG (C), change in postprandial glucose (PPG) (D), and percent change in body weight (E). SITA, sitagliptin; CANA, canagliflozin. *Statistical comparison for CANA 300 mg versus SITA 100 mg not performed (not prespecified).

Similar articles

Cited by

References

    1. American Diabetes Association. Standards of medical care in diabetes–2012. Diabetes Care 2012;35:S11–S63 - PMC - PubMed
    1. Inzucchi SE, Bergenstal RM, Buse JB, 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 - PMC - PubMed
    1. Cook MN, Girman CJ, Stein PP, Alexander CM, Holman RR. Glycemic control continues to deteriorate after sulfonylureas are added to metformin among patients with type 2 diabetes. Diabetes Care 2005;28:995–1000 - PubMed
    1. Gross JL, Kramer CK, Leitão CB, et al. Diabetes and Endocrinology Meta-analysis Group (DEMA) Effect of antihyperglycemic agents added to metformin and a sulfonylurea on glycemic control and weight gain in type 2 diabetes: a network meta-analysis. Ann Intern Med 2011;154:672–679 - PubMed
    1. National Institute for Health and Care Excellence. Type 2 diabetes: newer agents for blood glucose control in type 2 diabetes. NICE short clinical guideline 87.2009 - PubMed

Publication types

MeSH terms

Substances

LinkOut - more resources