Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial

Greg Fulcher; David R. Matthews; Vlado Perkovic; Dick de Zeeuw; Kenneth W. Mahaffey; Robert Weiss; Julio Rosenstock; George Capuano; Mehul Desai; Wayne Shaw; Frank Vercruysse; Gary Meininger; Bruce Neal

doi:10.1007/s13300-015-0117-z

Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial

Greg Fulcher^*, David R. Matthews, Vlado Perkovic, Dick de Zeeuw, Kenneth W. Mahaffey, Robert Weiss, Julio Rosenstock, George Capuano, Mehul Desai, Wayne Shaw, Frank Vercruysse, Gary Meininger, Bruce Neal

^*Corresponding author for this work

Groningen Kidney Center (GKC)

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

Introduction: The efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, was evaluated in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy.

Methods: The CANagliflozin cardioVascular Assessment Study (CANVAS) is a double-blind, placebo-controlled cardiovascular outcomes study that randomized participants to placebo or canagliflozin 100 or 300 mg once daily in addition to routine therapy. Participants in the CANVAS trial are men and women aged C30 years with T2DM and a history or high risk of cardiovascular disease, and inadequate glycemic control (glycated hemoglobin [HbA1c] >= 7.0% and

Results: Of the 4330 patients enrolled in CANVAS, 127 met the entry criteria for the sulfonylurea monotherapy substudy (placebo, n = 45; canagliflozin 100 mg, n = 42; canagliflozin 300 mg, n = 40). At 18 weeks, placebo-subtracted changes (95% confidence interval) in HbA1c were -0.74% (-1.15, -0.33; P

Conclusions: Canagliflozin added to ongoing sulfonylurea monotherapy produced improvements in HbA1c, FPG, and body weight, with an increased incidence of AEs consistent with the mechanism of action of SGLT2 inhibition.

Original language	English
Pages (from-to)	289-302
Number of pages	14
Journal	Diabetes Technol Ther
Volume	6
Issue number	3
DOIs	https://doi.org/10.1007/s13300-015-0117-z
Publication status	Published - Sept-2015

Keywords

Canagliflozin
Cardiovascular disease
SGLT2 inhibitor
Sulfonylureas
Type 2 diabetes
GLUCOSE COTRANSPORTER 2
CHRONIC KIDNEY-DISEASE
LONG-TERM EFFICACY
INHIBITOR
METFORMIN
MONOTHERAPY
METAANALYSIS
SITAGLIPTIN
EXERCISE
PLACEBO

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Fulcher, G., Matthews, D. R., Perkovic, V., de Zeeuw, D., Mahaffey, K. W., Weiss, R., Rosenstock, J., Capuano, G., Desai, M., Shaw, W., Vercruysse, F., Meininger, G., & Neal, B. (2015). Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial. Diabetes Technol Ther, 6(3), 289-302. https://doi.org/10.1007/s13300-015-0117-z

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title = "Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial",

abstract = "Introduction: The efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, was evaluated in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy.Methods: The CANagliflozin cardioVascular Assessment Study (CANVAS) is a double-blind, placebo-controlled cardiovascular outcomes study that randomized participants to placebo or canagliflozin 100 or 300 mg once daily in addition to routine therapy. Participants in the CANVAS trial are men and women aged C30 years with T2DM and a history or high risk of cardiovascular disease, and inadequate glycemic control (glycated hemoglobin [HbA1c] >= 7.0% andResults: Of the 4330 patients enrolled in CANVAS, 127 met the entry criteria for the sulfonylurea monotherapy substudy (placebo, n = 45; canagliflozin 100 mg, n = 42; canagliflozin 300 mg, n = 40). At 18 weeks, placebo-subtracted changes (95% confidence interval) in HbA1c were -0.74% (-1.15, -0.33; PConclusions: Canagliflozin added to ongoing sulfonylurea monotherapy produced improvements in HbA1c, FPG, and body weight, with an increased incidence of AEs consistent with the mechanism of action of SGLT2 inhibition.",

keywords = "Canagliflozin, Cardiovascular disease, SGLT2 inhibitor, Sulfonylureas, Type 2 diabetes, GLUCOSE COTRANSPORTER 2, CHRONIC KIDNEY-DISEASE, LONG-TERM EFFICACY, INHIBITOR, METFORMIN, MONOTHERAPY, METAANALYSIS, SITAGLIPTIN, EXERCISE, PLACEBO",

author = "Greg Fulcher and Matthews, {David R.} and Vlado Perkovic and {de Zeeuw}, Dick and Mahaffey, {Kenneth W.} and Robert Weiss and Julio Rosenstock and George Capuano and Mehul Desai and Wayne Shaw and Frank Vercruysse and Gary Meininger and Bruce Neal",

year = "2015",

month = sep,

doi = "10.1007/s13300-015-0117-z",

language = "English",

volume = "6",

pages = "289--302",

journal = "Diabetes Technol Ther",

issn = "1869-6953",

publisher = "SPRINGER HEIDELBERG",

number = "3",

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Fulcher, G, Matthews, DR, Perkovic, V, de Zeeuw, D, Mahaffey, KW, Weiss, R, Rosenstock, J, Capuano, G, Desai, M, Shaw, W, Vercruysse, F, Meininger, G & Neal, B 2015, 'Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial', Diabetes Technol Ther, vol. 6, no. 3, pp. 289-302. https://doi.org/10.1007/s13300-015-0117-z

TY - JOUR

T1 - Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus

T2 - A Randomized, Controlled Trial

AU - Fulcher, Greg

AU - Matthews, David R.

AU - Perkovic, Vlado

AU - de Zeeuw, Dick

AU - Mahaffey, Kenneth W.

AU - Weiss, Robert

AU - Rosenstock, Julio

AU - Capuano, George

AU - Desai, Mehul

AU - Shaw, Wayne

AU - Vercruysse, Frank

AU - Meininger, Gary

AU - Neal, Bruce

PY - 2015/9

Y1 - 2015/9

N2 - Introduction: The efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, was evaluated in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy.Methods: The CANagliflozin cardioVascular Assessment Study (CANVAS) is a double-blind, placebo-controlled cardiovascular outcomes study that randomized participants to placebo or canagliflozin 100 or 300 mg once daily in addition to routine therapy. Participants in the CANVAS trial are men and women aged C30 years with T2DM and a history or high risk of cardiovascular disease, and inadequate glycemic control (glycated hemoglobin [HbA1c] >= 7.0% andResults: Of the 4330 patients enrolled in CANVAS, 127 met the entry criteria for the sulfonylurea monotherapy substudy (placebo, n = 45; canagliflozin 100 mg, n = 42; canagliflozin 300 mg, n = 40). At 18 weeks, placebo-subtracted changes (95% confidence interval) in HbA1c were -0.74% (-1.15, -0.33; PConclusions: Canagliflozin added to ongoing sulfonylurea monotherapy produced improvements in HbA1c, FPG, and body weight, with an increased incidence of AEs consistent with the mechanism of action of SGLT2 inhibition.

AB - Introduction: The efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, was evaluated in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy.Methods: The CANagliflozin cardioVascular Assessment Study (CANVAS) is a double-blind, placebo-controlled cardiovascular outcomes study that randomized participants to placebo or canagliflozin 100 or 300 mg once daily in addition to routine therapy. Participants in the CANVAS trial are men and women aged C30 years with T2DM and a history or high risk of cardiovascular disease, and inadequate glycemic control (glycated hemoglobin [HbA1c] >= 7.0% andResults: Of the 4330 patients enrolled in CANVAS, 127 met the entry criteria for the sulfonylurea monotherapy substudy (placebo, n = 45; canagliflozin 100 mg, n = 42; canagliflozin 300 mg, n = 40). At 18 weeks, placebo-subtracted changes (95% confidence interval) in HbA1c were -0.74% (-1.15, -0.33; PConclusions: Canagliflozin added to ongoing sulfonylurea monotherapy produced improvements in HbA1c, FPG, and body weight, with an increased incidence of AEs consistent with the mechanism of action of SGLT2 inhibition.

KW - Canagliflozin

KW - Cardiovascular disease

KW - SGLT2 inhibitor

KW - Sulfonylureas

KW - Type 2 diabetes

KW - GLUCOSE COTRANSPORTER 2

KW - CHRONIC KIDNEY-DISEASE

KW - LONG-TERM EFFICACY

KW - INHIBITOR

KW - METFORMIN

KW - MONOTHERAPY

KW - METAANALYSIS

KW - SITAGLIPTIN

KW - EXERCISE

KW - PLACEBO

U2 - 10.1007/s13300-015-0117-z

DO - 10.1007/s13300-015-0117-z

M3 - Article

C2 - 26081793

SN - 1869-6953

VL - 6

SP - 289

EP - 302

JO - Diabetes Technol Ther

JF - Diabetes Technol Ther

IS - 3

ER -

Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial

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Keywords

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