Dose-Ranging Effects of Canagliflozin, a Sodium-Glucose Cotransporter 2 Inhibitor, as Add-On to Metformin in Subjects With Type 2 Diabetes
To evaluate the effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in type 2 diabetes mellitus inadequately controlled with metformin monotherapy. This was a double-blind, placebo-controlled, parallel-group, multicenter, dose-ranging study in 451 subjects randomized to canaglifloz...
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| Published in | Diabetes care Vol. 35; no. 6; pp. 1232 - 1238 |
|---|---|
| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Alexandria, VA
American Diabetes Association
01.06.2012
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0149-5992 1935-5548 1935-5548 |
| DOI | 10.2337/dc11-1926 |
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| Abstract | To evaluate the effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in type 2 diabetes mellitus inadequately controlled with metformin monotherapy.
This was a double-blind, placebo-controlled, parallel-group, multicenter, dose-ranging study in 451 subjects randomized to canagliflozin 50, 100, 200, or 300 mg once daily (QD) or 300 mg twice daily (BID), sitagliptin 100 mg QD, or placebo. Primary end point was change in A1C from baseline through week 12. Secondary end points included change in fasting plasma glucose (FPG), body weight, and overnight urinary glucose-to-creatinine ratio. Safety and tolerability were also assessed.
Canagliflozin was associated with significant reductions in A1C from baseline (7.6-8.0%) to week 12: -0.79, -0.76, -0.70, -0.92, and -0.95% for canagliflozin 50, 100, 200, 300 mg QD and 300 mg BID, respectively, versus -0.22% for placebo (all P < 0.001) and -0.74% for sitagliptin. FPG was reduced by -16 to -27 mg/dL, and body weight was reduced by -2.3 to -3.4%, with significant increases in urinary glucose-to-creatinine ratio. Adverse events were transient, mild to moderate, and balanced across arms except for a non-dose-dependent increase in symptomatic genital infections with canagliflozin (3-8%) versus placebo and sitagliptin (2%). Urinary tract infections were reported without dose dependency in 3-9% of canagliflozin, 6% of placebo, and 2% of sitagliptin arms. Overall incidence of hypoglycemia was low.
Canagliflozin added onto metformin significantly improved glycemic control in type 2 diabetes and was associated with low incidence of hypoglycemia and significant weight loss. The safety/tolerability profile of canagliflozin was favorable except for increased frequency of genital infections in females. |
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| AbstractList | To evaluate the effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in type 2 diabetes mellitus inadequately controlled with metformin monotherapy.OBJECTIVETo evaluate the effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in type 2 diabetes mellitus inadequately controlled with metformin monotherapy.This was a double-blind, placebo-controlled, parallel-group, multicenter, dose-ranging study in 451 subjects randomized to canagliflozin 50, 100, 200, or 300 mg once daily (QD) or 300 mg twice daily (BID), sitagliptin 100 mg QD, or placebo. Primary end point was change in A1C from baseline through week 12. Secondary end points included change in fasting plasma glucose (FPG), body weight, and overnight urinary glucose-to-creatinine ratio. Safety and tolerability were also assessed.RESEARCH DESIGN AND METHODSThis was a double-blind, placebo-controlled, parallel-group, multicenter, dose-ranging study in 451 subjects randomized to canagliflozin 50, 100, 200, or 300 mg once daily (QD) or 300 mg twice daily (BID), sitagliptin 100 mg QD, or placebo. Primary end point was change in A1C from baseline through week 12. Secondary end points included change in fasting plasma glucose (FPG), body weight, and overnight urinary glucose-to-creatinine ratio. Safety and tolerability were also assessed.Canagliflozin was associated with significant reductions in A1C from baseline (7.6-8.0%) to week 12: -0.79, -0.76, -0.70, -0.92, and -0.95% for canagliflozin 50, 100, 200, 300 mg QD and 300 mg BID, respectively, versus -0.22% for placebo (all P < 0.001) and -0.74% for sitagliptin. FPG was reduced by -16 to -27 mg/dL, and body weight was reduced by -2.3 to -3.4%, with significant increases in urinary glucose-to-creatinine ratio. Adverse events were transient, mild to moderate, and balanced across arms except for a non-dose-dependent increase in symptomatic genital infections with canagliflozin (3-8%) versus placebo and sitagliptin (2%). Urinary tract infections were reported without dose dependency in 3-9% of canagliflozin, 6% of placebo, and 2% of sitagliptin arms. Overall incidence of hypoglycemia was low.RESULTSCanagliflozin was associated with significant reductions in A1C from baseline (7.6-8.0%) to week 12: -0.79, -0.76, -0.70, -0.92, and -0.95% for canagliflozin 50, 100, 200, 300 mg QD and 300 mg BID, respectively, versus -0.22% for placebo (all P < 0.001) and -0.74% for sitagliptin. FPG was reduced by -16 to -27 mg/dL, and body weight was reduced by -2.3 to -3.4%, with significant increases in urinary glucose-to-creatinine ratio. Adverse events were transient, mild to moderate, and balanced across arms except for a non-dose-dependent increase in symptomatic genital infections with canagliflozin (3-8%) versus placebo and sitagliptin (2%). Urinary tract infections were reported without dose dependency in 3-9% of canagliflozin, 6% of placebo, and 2% of sitagliptin arms. Overall incidence of hypoglycemia was low.Canagliflozin added onto metformin significantly improved glycemic control in type 2 diabetes and was associated with low incidence of hypoglycemia and significant weight loss. The safety/tolerability profile of canagliflozin was favorable except for increased frequency of genital infections in females.CONCLUSIONSCanagliflozin added onto metformin significantly improved glycemic control in type 2 diabetes and was associated with low incidence of hypoglycemia and significant weight loss. The safety/tolerability profile of canagliflozin was favorable except for increased frequency of genital infections in females. To evaluate the effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in type 2 diabetes mellitus inadequately controlled with metformin monotherapy. This was a double-blind, placebo-controlled, parallel-group, multicenter, dose-ranging study in 451 subjects randomized to canagliflozin 50, 100, 200, or 300 mg once daily (QD) or 300 mg twice daily (BID), sitagliptin 100 mg QD, or placebo. Primary end point was change in A1C from baseline through week 12. Secondary end points included change in fasting plasma glucose (FPG), body weight, and overnight urinary glucose-to-creatinine ratio. Safety and tolerability were also assessed. Canagliflozin was associated with significant reductions in A1C from baseline (7.6-8.0%) to week 12: -0.79, -0.76, -0.70, -0.92, and -0.95% for canagliflozin 50, 100, 200, 300 mg QD and 300 mg BID, respectively, versus -0.22% for placebo (all P < 0.001) and -0.74% for sitagliptin. FPG was reduced by -16 to -27 mg/dL, and body weight was reduced by -2.3 to -3.4%, with significant increases in urinary glucose-to-creatinine ratio. Adverse events were transient, mild to moderate, and balanced across arms except for a non-dose-dependent increase in symptomatic genital infections with canagliflozin (3-8%) versus placebo and sitagliptin (2%). Urinary tract infections were reported without dose dependency in 3-9% of canagliflozin, 6% of placebo, and 2% of sitagliptin arms. Overall incidence of hypoglycemia was low. Canagliflozin added onto metformin significantly improved glycemic control in type 2 diabetes and was associated with low incidence of hypoglycemia and significant weight loss. The safety/tolerability profile of canagliflozin was favorable except for increased frequency of genital infections in females. OBJECTIVE: To evaluate the effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in type 2 diabetes mellitus inadequately controlled with metformin monotherapy. RESEARCH DESIGN AND METHODS: This was a double-blind, placebo-controlled, parallel-group, multicenter, dose-ranging study in 451 subjects randomized to canagliflozin 50, 100, 200, or 300 mg once daily (QD) or 300 mg twice daily (BID), sitagliptin 100 mg QD, or placebo. Primary end point was change in A1C from baseline through week 12. Secondary end points included change in fasting plasma glucose (FPG), body weight, and overnight urinary glucose-to-creatinine ratio. Safety and tolerability were also assessed. RESULTS: Canagliflozin was associated with significant reductions in A1C from baseline (7.6–8.0%) to week 12: –0.79, –0.76, –0.70, –0.92, and –0.95% for canagliflozin 50, 100, 200, 300 mg QD and 300 mg BID, respectively, versus –0.22% for placebo (all P < 0.001) and –0.74% for sitagliptin. FPG was reduced by –16 to –27 mg/dL, and body weight was reduced by –2.3 to –3.4%, with significant increases in urinary glucose-to-creatinine ratio. Adverse events were transient, mild to moderate, and balanced across arms except for a non–dose-dependent increase in symptomatic genital infections with canagliflozin (3–8%) versus placebo and sitagliptin (2%). Urinary tract infections were reported without dose dependency in 3–9% of canagliflozin, 6% of placebo, and 2% of sitagliptin arms. Overall incidence of hypoglycemia was low. CONCLUSIONS: Canagliflozin added onto metformin significantly improved glycemic control in type 2 diabetes and was associated with low incidence of hypoglycemia and significant weight loss. The safety/tolerability profile of canagliflozin was favorable except for increased frequency of genital infections in females. To evaluate the effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in type 2 diabetes mellitus inadequately controlled with metformin monotherapy. This was a double-blind, placebo-controlled, parallel-group, multicenter, dose-ranging study in 451 subjects randomized to canagliflozin 50, 100, 200, or 300 mg once daily (QD) or 300 mg twice daily (BID), sitagliptin 100 mg QD, or placebo. Primary end point was change in A1C from baseline through week 12. Secondary end points included change in fasting plasma glucose (FPG), body weight, and overnight urinary glucose-to-creatinine ratio. Safety and tolerability were also assessed. Canagliflozin was associated with significant reductions in A1C from baseline (7.6-8.0%) to week 12: -0.79, -0.76, -0.70, -0.92, and -0.95% for canagliflozin 50, 100, 200, 300 mg QD and 300 mg BID, respectively, versus -0.22% for placebo (all P < 0.001) and -0.74% for sitagliptin. FPG was reduced by - 16 to -27 mg/dL, and body weight was reduced by -2.3 to -3.4%, with significant increases in urinary glucose-to-creatinine ratio. Adverse events were transient, mild to moderate, and balanced across arms except for a non-dose-dependent increase in symptomatic genital infections with canagliflozin (3-8%) versus placebo and sitagliptin (2%). Urinary tract infections were reported without dose dependency in 3-9% of canagliflozin, 6% of placebo, and 2% of sitagliptin arms. Overall incidence of hypoglycemia was low. Canagliflozin added onto metformin significantly improved glycemic control in type 2 diabetes and was associated with low incidence of hypoglycemia and significant weight loss. The safety/tolerability profile of canagliflozin was favorable except for increased frequency of genital infections in females. |
| Audience | Professional |
| Author | Capuano, George Zhao, Yue Rosenstock, Julio Polidori, David Arbit, Deborah Usiskin, Keith Canovatchel, William Aggarwal, Naresh |
| Author_xml | – sequence: 1 givenname: Julio surname: Rosenstock fullname: Rosenstock, Julio organization: Dallas Diabetes and Endocrine Center at Medical City, Dallas, Texas – sequence: 2 givenname: Naresh surname: Aggarwal fullname: Aggarwal, Naresh organization: Aggarwal & Associates Ltd., Brampton, Ontario, Canada – sequence: 3 givenname: David surname: Polidori fullname: Polidori, David organization: Janssen Global Services, LLC, La Jolla, California – sequence: 4 givenname: Yue surname: Zhao fullname: Zhao, Yue organization: Janssen Global Services, LLC, Raritan, New Jersey – sequence: 5 givenname: Deborah surname: Arbit fullname: Arbit, Deborah organization: Janssen Global Services, LLC, Raritan, New Jersey – sequence: 6 givenname: Keith surname: Usiskin fullname: Usiskin, Keith organization: Janssen Global Services, LLC, Raritan, New Jersey – sequence: 7 givenname: George surname: Capuano fullname: Capuano, George organization: Janssen Global Services, LLC, Raritan, New Jersey – sequence: 8 givenname: William surname: Canovatchel fullname: Canovatchel, William organization: Janssen Global Services, LLC, Raritan, New Jersey |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25944988$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/22492586$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Dowell, Anthony Jadzinsky, Maurico Barranco, Elizabeth Dohnalova, Lenka Sivkova, Elena Eliaschewitz, Freddy Schabowski, Janusz Ceska, Richard Loba, Jerzy Verbovoy, Andrey Stringam, Stanley Coman, Anca Ileana Chrysant, Steven MacLeod, Ken Guerra, Flavio Sosa- Padilla, Miguel Vorokhobina, Natalia Landgarten, Steven Messina, Nicholas Rios, Esteban Caldwell, Ian Cinlikov, Ivan King, Mark Aggarwal, Naresh Gallery, Christian Seifert, Bohumil Albota, Adrian Quigley, James Gorfinkel, Iris Calvo, Cesar Komrskova, Miloslava Morosanu, Maevery dayalena Foczpaniak, Maciej Pitale, Shailesh Polaszewska-Muszynska, Miroslawa Conway, Martin Antunez, Paula Nosova, Nina Jain, Rajeev Kanani, Subodh Tankova, Tsvetalina Schramm, Erich Vallieres, Camil Grineva, Elena Jonakin, William Bell, Patrick Brychta, Tomas Kale, Shailaja Kamaruddin, Nor Azmi Chan, Siew Pheng Stasinska, Teresa Cohen, Kenneth Shu, Daniel Rosenstock, Julio Alpizar, Melchor Leiter, Lawrence Hershon, Kenneth S Shamanna, Paramesh Hudrick, Robert Semetkowka, Ewa Andresova, Alena Maffei, Laura Halpern, Al |
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| Copyright | 2015 INIST-CNRS COPYRIGHT 2012 American Diabetes Association Copyright American Diabetes Association Jun 2012 2012 by the American Diabetes Association. 2012 |
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| References | Wright (2022031302550342400_B3) 2007; 261 Goswami (2022031302550342400_B13) 2000; 41 Komoroski (2022031302550342400_B4) 2009; 85 2022031302550342400_B8 2022031302550342400_B7 2022031302550342400_B14 Ferrannini (2022031302550342400_B16) 2010; 25 Caulfield (2022031302550342400_B17) 2008; 5 2022031302550342400_B9 Musso (2022031302550342400_B15) 2011 [ ] Rossetti (2022031302550342400_B10) 1987; 80 Bagga (2022031302550342400_B6) 2005; 72 Cheung (2022031302550342400_B1) 2009; 122 Sha (2022031302550342400_B5) 2011; 13 Gumbiner (2022031302550342400_B11) 1990; 70 Geerlings (2022031302550342400_B12) 2000; 23 Bakris (2022031302550342400_B2) 2009; 75 19375554 - Am J Med. 2009 May;122(5):443-53 19129748 - Clin Pharmacol Ther. 2009 May;85(5):520-6 20466683 - Nephrol Dial Transplant. 2010 Jul;25(7):2041-3 11023762 - J Infect. 2000 Sep;41(2):162-6 3308956 - J Clin Invest. 1987 Oct;80(4):1037-44 11128343 - Diabetes Care. 2000 Dec;23(12):1737-41 18842065 - PLoS Med. 2008 Oct 7;5(10):e197 21457428 - Diabetes Obes Metab. 2011 Jul;13(7):669-72 16186680 - Indian J Pediatr. 2005 Sep;72(9):771-6 21495788 - Ann Med. 2012 Jun;44(4):375-93 2189885 - J Clin Endocrinol Metab. 1990 Jun;70(6):1594-602 17222166 - J Intern Med. 2007 Jan;261(1):32-43 19357717 - Kidney Int. 2009 Jun;75(12):1272-7 |
| References_xml | – volume: 80 start-page: 1037 year: 1987 ident: 2022031302550342400_B10 article-title: Effect of chronic hyperglycemia on in vivo insulin secretion in partially pancreatectomized rats publication-title: J Clin Invest doi: 10.1172/JCI113157 – volume: 23 start-page: 1737 year: 2000 ident: 2022031302550342400_B12 article-title: Risk factors for symptomatic urinary tract infection in women with diabetes publication-title: Diabetes Care doi: 10.2337/diacare.23.12.1737 – volume: 122 start-page: 443 year: 2009 ident: 2022031302550342400_B1 article-title: Diabetes prevalence and therapeutic target achievement in the United States, 1999 to 2006 publication-title: Am J Med doi: 10.1016/j.amjmed.2008.09.047 – volume: 25 start-page: 2041 year: 2010 ident: 2022031302550342400_B16 article-title: Sodium-glucose transporter-2 inhibition as an antidiabetic therapy publication-title: Nephrol Dial Transplant doi: 10.1093/ndt/gfq249 – year: 2011 [ ] ident: 2022031302550342400_B15 article-title: A novel approach to control hyperglycemia in type 2 diabetes: Sodium glucose co-transport (SGLT) inhibitors. Systematic review and meta-analysis of randomized trials publication-title: Ann Med. – volume: 261 start-page: 32 year: 2007 ident: 2022031302550342400_B3 article-title: Active sugar transport in health and disease publication-title: J Intern Med doi: 10.1111/j.1365-2796.2006.01746.x – volume: 72 start-page: 771 year: 2005 ident: 2022031302550342400_B6 article-title: Approach to renal tubular disorders publication-title: Indian J Pediatr doi: 10.1007/BF02734150 – ident: 2022031302550342400_B7 – ident: 2022031302550342400_B8 – ident: 2022031302550342400_B9 – volume: 70 start-page: 1594 year: 1990 ident: 2022031302550342400_B11 article-title: Effects of weight loss and reduced hyperglycemia on the kinetics of insulin secretion in obese non-insulin dependent diabetes mellitus publication-title: J Clin Endocrinol Metab doi: 10.1210/jcem-70-6-1594 – ident: 2022031302550342400_B14 – volume: 75 start-page: 1272 year: 2009 ident: 2022031302550342400_B2 article-title: Renal sodium-glucose transport: role in diabetes mellitus and potential clinical implications publication-title: Kidney Int doi: 10.1038/ki.2009.87 – volume: 13 start-page: 669 year: 2011 ident: 2022031302550342400_B5 article-title: Canagliflozin, a novel inhibitor of sodium glucose co-transporter 2, dose dependently reduces calculated renal threshold for glucose excretion and increases urinary glucose excretion in healthy subjects publication-title: Diabetes Obes Metab doi: 10.1111/j.1463-1326.2011.01406.x – volume: 5 start-page: e197 year: 2008 ident: 2022031302550342400_B17 article-title: SLC2A9 is a high-capacity urate transporter in humans publication-title: PLoS Med doi: 10.1371/journal.pmed.0050197 – volume: 85 start-page: 520 year: 2009 ident: 2022031302550342400_B4 article-title: Dapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent glucosuria in healthy subjects publication-title: Clin Pharmacol Ther doi: 10.1038/clpt.2008.251 – volume: 41 start-page: 162 year: 2000 ident: 2022031302550342400_B13 article-title: Species-specific prevalence of vaginal candidiasis among patients with diabetes mellitus and its relation to their glycaemic status publication-title: J Infect doi: 10.1053/jinf.2000.0723 – reference: 19375554 - Am J Med. 2009 May;122(5):443-53 – reference: 21495788 - Ann Med. 2012 Jun;44(4):375-93 – reference: 21457428 - Diabetes Obes Metab. 2011 Jul;13(7):669-72 – reference: 17222166 - J Intern Med. 2007 Jan;261(1):32-43 – reference: 19129748 - Clin Pharmacol Ther. 2009 May;85(5):520-6 – reference: 2189885 - J Clin Endocrinol Metab. 1990 Jun;70(6):1594-602 – reference: 16186680 - Indian J Pediatr. 2005 Sep;72(9):771-6 – reference: 19357717 - Kidney Int. 2009 Jun;75(12):1272-7 – reference: 18842065 - PLoS Med. 2008 Oct 7;5(10):e197 – reference: 11023762 - J Infect. 2000 Sep;41(2):162-6 – reference: 11128343 - Diabetes Care. 2000 Dec;23(12):1737-41 – reference: 20466683 - Nephrol Dial Transplant. 2010 Jul;25(7):2041-3 – reference: 3308956 - J Clin Invest. 1987 Oct;80(4):1037-44 |
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| Snippet | To evaluate the effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in type 2 diabetes mellitus inadequately controlled with metformin... OBJECTIVE: To evaluate the effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in type 2 diabetes mellitus inadequately controlled with... |
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| SubjectTerms | administration & dosage Adolescent Adult Aged Biological and medical sciences blood blood glucose Blood Glucose - drug effects Blood Glucose - metabolism Body weight Canagliflozin chemically induced Dextrose Diabetes Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Diabetes therapy Diabetes. Impaired glucose tolerance Dose-Response Relationship, Drug Double-Blind Method drug effects drug therapy Drug Therapy, Combination Endocrine pancreas. Apud cells (diseases) Endocrinopathies Etiopathogenesis. Screening. Investigations. Target tissue resistance fasting Female females Glucose Glucosides Glucosides - administration & dosage Glucosides - pharmacology glycemic control Humans hypoglycemia Hypoglycemia - blood Hypoglycemia - chemically induced Hypoglycemic Agents Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - pharmacology Male Medical sciences Metabolic diseases metabolism metformin Metformin - administration & dosage Metformin - pharmacology Middle Aged Miscellaneous noninsulin-dependent diabetes mellitus Original Research pharmacology Plasma Public health. Hygiene Public health. Hygiene-occupational medicine Sodium Sodium-Glucose Transporter 2 - antagonists & inhibitors Sodium-Glucose Transporter 2 Inhibitors Statistical methods Thiophenes Thiophenes - administration & dosage Thiophenes - pharmacology Treatment Outcome Type 2 diabetes urinary tract diseases weight loss Weight Loss - drug effects Young Adult |
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| Title | Dose-Ranging Effects of Canagliflozin, a Sodium-Glucose Cotransporter 2 Inhibitor, as Add-On to Metformin in Subjects With Type 2 Diabetes |
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