Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus
Aim: To evaluate the efficacy/safety of canagliflozin twice daily (BID) compared with placebo in patients with type 2 diabetes mellitus (T2DM) on metformin. Methods: In this 18-week, randomized, double-blind, placebo-controlled study, patients (N = 279) at 60 centers in 7 countries received canaglif...
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| Format: | Article |
| Language: | English |
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Elsevier
2014-06-01
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| Series: | Journal of Clinical & Translational Endocrinology |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2214623714000143 |
| _version_ | 1818515983943335936 |
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| author | Rong Qiu, MD, PhD George Capuano, PhD Gary Meininger, MD |
| author_facet | Rong Qiu, MD, PhD George Capuano, PhD Gary Meininger, MD |
| author_sort | Rong Qiu, MD, PhD |
| collection | DOAJ |
| description | Aim: To evaluate the efficacy/safety of canagliflozin twice daily (BID) compared with placebo in patients with type 2 diabetes mellitus (T2DM) on metformin.
Methods: In this 18-week, randomized, double-blind, placebo-controlled study, patients (N = 279) at 60 centers in 7 countries received canagliflozin 50 or 150 mg or placebo BID. The pre-specified primary endpoint was change from baseline in HbA1c at Week 18. Pre-specified secondary endpoints included proportion of patients reaching HbA1c <7.0%, change in fasting plasma glucose (FPG), and percent change in body weight; changes in systolic blood pressure (BP) and fasting plasma lipids were also evaluated. Adverse events (AEs) were recorded throughout the study.
Results: From a mean baseline HbA1c of 7.6% (60 mmol/mol), canagliflozin 50 and 150 mg BID significantly reduced HbA1c compared with placebo at Week 18 (−0.45%, −0.61%, −0.01% [−5, −7, −0.1 mmol/mol], respectively; P < 0.001). More patients achieved HbA1c <7.0% with canagliflozin than placebo (P < 0.05). Relative to placebo, both canagliflozin doses significantly lowered FPG and body weight (P < 0.001), and reduced systolic BP. Overall AE incidence was 35.5%, 40.9%, and 36.6% with canagliflozin 50 and 150 mg BID and placebo, respectively. Canagliflozin was associated with increased incidences of urinary tract infections, female genital mycotic infections, and osmotic diuresis-related AEs; these led to few discontinuations. The incidence of documented hypoglycemia was low across groups.
Conclusions: Canagliflozin 50 and 150 mg BID provided significant glycemic efficacy and body weight reduction, and were generally well tolerated in patients with T2DM on background metformin.
ClinicalTrials.gov Identifier: NCT01340664 |
| first_indexed | 2024-12-11T00:36:04Z |
| format | Article |
| id | doaj.art-44ba6cc1b28047cbab5cd91b00bb59b4 |
| institution | Directory Open Access Journal |
| issn | 2214-6237 |
| language | English |
| last_indexed | 2024-12-11T00:36:04Z |
| publishDate | 2014-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Clinical & Translational Endocrinology |
| spelling | doaj.art-44ba6cc1b28047cbab5cd91b00bb59b42022-12-22T01:27:08ZengElsevierJournal of Clinical & Translational Endocrinology2214-62372014-06-0112546010.1016/j.jcte.2014.04.001Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitusRong Qiu, MD, PhDGeorge Capuano, PhDGary Meininger, MDAim: To evaluate the efficacy/safety of canagliflozin twice daily (BID) compared with placebo in patients with type 2 diabetes mellitus (T2DM) on metformin. Methods: In this 18-week, randomized, double-blind, placebo-controlled study, patients (N = 279) at 60 centers in 7 countries received canagliflozin 50 or 150 mg or placebo BID. The pre-specified primary endpoint was change from baseline in HbA1c at Week 18. Pre-specified secondary endpoints included proportion of patients reaching HbA1c <7.0%, change in fasting plasma glucose (FPG), and percent change in body weight; changes in systolic blood pressure (BP) and fasting plasma lipids were also evaluated. Adverse events (AEs) were recorded throughout the study. Results: From a mean baseline HbA1c of 7.6% (60 mmol/mol), canagliflozin 50 and 150 mg BID significantly reduced HbA1c compared with placebo at Week 18 (−0.45%, −0.61%, −0.01% [−5, −7, −0.1 mmol/mol], respectively; P < 0.001). More patients achieved HbA1c <7.0% with canagliflozin than placebo (P < 0.05). Relative to placebo, both canagliflozin doses significantly lowered FPG and body weight (P < 0.001), and reduced systolic BP. Overall AE incidence was 35.5%, 40.9%, and 36.6% with canagliflozin 50 and 150 mg BID and placebo, respectively. Canagliflozin was associated with increased incidences of urinary tract infections, female genital mycotic infections, and osmotic diuresis-related AEs; these led to few discontinuations. The incidence of documented hypoglycemia was low across groups. Conclusions: Canagliflozin 50 and 150 mg BID provided significant glycemic efficacy and body weight reduction, and were generally well tolerated in patients with T2DM on background metformin. ClinicalTrials.gov Identifier: NCT01340664http://www.sciencedirect.com/science/article/pii/S2214623714000143Type 2 diabetes mellitusSodium glucose co-transporter 2 (SGLT2) inhibitorCanagliflozinMetforminTwice daily (BID) |
| spellingShingle | Rong Qiu, MD, PhD George Capuano, PhD Gary Meininger, MD Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus Journal of Clinical & Translational Endocrinology Type 2 diabetes mellitus Sodium glucose co-transporter 2 (SGLT2) inhibitor Canagliflozin Metformin Twice daily (BID) |
| title | Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus |
| title_full | Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus |
| title_fullStr | Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus |
| title_full_unstemmed | Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus |
| title_short | Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus |
| title_sort | efficacy and safety of twice daily treatment with canagliflozin a sodium glucose co transporter 2 inhibitor added on to metformin monotherapy in patients with type 2 diabetes mellitus |
| topic | Type 2 diabetes mellitus Sodium glucose co-transporter 2 (SGLT2) inhibitor Canagliflozin Metformin Twice daily (BID) |
| url | http://www.sciencedirect.com/science/article/pii/S2214623714000143 |
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