Canagliflozin in Asian patients with type 2 diabetes on metformin alone or metformin in combination with sulphonylurea
Linong Ji,1 Ping Han,2 Yu Liu,3 Gangyi Yang,4 Nguyen Khoa Dieu Van,5 Ujjwala Vijapurkar,6 Rose Qiu,6 Gary Meininger6
1
Peking University People’s Hospital, Peking University Diabetes Center, Beijing, China;
2
Shengjing Hospital of China Medical University, Shenyang, China; 3The Second Hospital of
Jilin University, Changchun, China; 4The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China; 5Endocrinology Department, Bach Mai Hospital, Hanoi, Vietnam; 6Janssen Research & Development, LLC, Raritan, NJ, USA.
Correspondence to: Linong Ji, MD Peking University People’s Hospital Peking University Diabetes Center Beijing, China Tel: +861088324108 Fax: +861068318386 E-mail: [email protected]
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/dom.12385
This article is protected by copyright. All rights reserved
ABSTRACT Aims: The efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, were evaluated in Asian patients with type 2 diabetes mellitus (T2DM) inadequately controlled by metformin or metformin + sulphonylurea. Materials and methods: In this 18-week, randomized, double-blind, placebo-controlled phase 3 study, patients (N=676) received canagliflozin 100 or 300 mg or placebo once daily. The primary efficacy endpoint was change in HbA1c from baseline at week 18; additional endpoints included change in fasting plasma glucose (FPG) and percent change in body weight. Adverse events (AEs) were recorded throughout the study. Efficacy and safety were assessed in the overall population and in two strata based on background therapy. Results: At week 18, canagliflozin 100 and 300 mg provided significant reductions from baseline in HbA1c compared with placebo (–0.97%, –1.06%, and –0.47%, respectively; p 13.3 mmol/l (240 mg/dl); after week 12 through week 18, FPG >11.1 mmol/l (200 mg/dl)].
Study Endpoints and Assessments Efficacy and safety were evaluated in the overall population and in two strata based on background therapy (i.e. metformin alone or metformin + sulphonylurea). The primary
This article is protected by copyright. All rights reserved
efficacy endpoint was the change in HbA1c from baseline to week 18. Other pre-specified efficacy endpoints included change from baseline in FPG and percent change in body weight at week 18. Change in systolic and diastolic BP, percent changes in fasting lipids, and the proportion of patients achieving HbA1c
Linong Ji,1 Ping Han,2 Yu Liu,3 Gangyi Yang,4 Nguyen Khoa Dieu Van,5 Ujjwala Vijapurkar,6 Rose Qiu,6 Gary Meininger6
1
Peking University People’s Hospital, Peking University Diabetes Center, Beijing, China;
2
Shengjing Hospital of China Medical University, Shenyang, China; 3The Second Hospital of
Jilin University, Changchun, China; 4The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China; 5Endocrinology Department, Bach Mai Hospital, Hanoi, Vietnam; 6Janssen Research & Development, LLC, Raritan, NJ, USA.
Correspondence to: Linong Ji, MD Peking University People’s Hospital Peking University Diabetes Center Beijing, China Tel: +861088324108 Fax: +861068318386 E-mail: [email protected]
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/dom.12385
This article is protected by copyright. All rights reserved
ABSTRACT Aims: The efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, were evaluated in Asian patients with type 2 diabetes mellitus (T2DM) inadequately controlled by metformin or metformin + sulphonylurea. Materials and methods: In this 18-week, randomized, double-blind, placebo-controlled phase 3 study, patients (N=676) received canagliflozin 100 or 300 mg or placebo once daily. The primary efficacy endpoint was change in HbA1c from baseline at week 18; additional endpoints included change in fasting plasma glucose (FPG) and percent change in body weight. Adverse events (AEs) were recorded throughout the study. Efficacy and safety were assessed in the overall population and in two strata based on background therapy. Results: At week 18, canagliflozin 100 and 300 mg provided significant reductions from baseline in HbA1c compared with placebo (–0.97%, –1.06%, and –0.47%, respectively; p 13.3 mmol/l (240 mg/dl); after week 12 through week 18, FPG >11.1 mmol/l (200 mg/dl)].
Study Endpoints and Assessments Efficacy and safety were evaluated in the overall population and in two strata based on background therapy (i.e. metformin alone or metformin + sulphonylurea). The primary
This article is protected by copyright. All rights reserved
efficacy endpoint was the change in HbA1c from baseline to week 18. Other pre-specified efficacy endpoints included change from baseline in FPG and percent change in body weight at week 18. Change in systolic and diastolic BP, percent changes in fasting lipids, and the proportion of patients achieving HbA1c
