The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)

NCT01106677 | Completed Phase 3 Results DMC

• 2 other identifiers: CR01702328431754DIA3006
• Study Type: interventional
• Target: 1,284
• Locations: 22 countries
• Sites: 125

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin and placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (i.e., treatment with a single drug) and have inadequate glycemic (blood sugar) control.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitus; Canagliflozin; Placebo; Sitagliptin; Januvia; Metformin Immediate Release (IR); Hemoglobin A1c

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline to Week 26

  The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.

  Day 1 (Baseline) and Week 26

Secondary Outcomes (13)

• Percentage of Patients With HbA1c <7% at Week 26

  Week 26

• Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

  Day 1 (Baseline) and Week 26

• Change in 2-hour Post-prandial Glucose From Baseline to Week 26

  Day 1 (Baseline) and Week 26

• Percent Change in Body Weight From Baseline to Week 26

  Day 1 (Baseline) and Week 26

• Change in Systolic Blood Pressure (SBP) From Baseline to Week 26

  Day 1 (Baseline) and Week 26

Study Arms (4)

Canagliflozin 100 mg

EXPERIMENTAL

Each patient will receive 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.

Drug: Canagliflozin; Drug: Metformin immediate release

Canagliflozin 300 mg

EXPERIMENTAL

Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.

Drug: Canagliflozin; Drug: Metformin immediate release

Sitagliptin 100 mg

ACTIVE COMPARATOR

Each patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.

Drug: Sitagliptin; Drug: Metformin immediate release

Placebo/Sitagliptin

OTHER

Each patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin will be given with protocol-specified doses of metformin immediate release.

Drug: Placebo; Drug: Sitagliptin; Drug: Metformin immediate release

Interventions

Placebo DRUG

One matching placebo capsule orally (by mouth) once daily for 26 weeks with protocol-specified doses of metformin immediate release.

Placebo/Sitagliptin

Canagliflozin DRUG

One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with protocol-specified doses of metformin immediate release.

Canagliflozin 100 mg; Canagliflozin 300 mg

Sitagliptin DRUG

One 100 mg over-encapsulated tablet orally once daily for 52 weeks (sitagliptin 100 mg arm) or once daily beginning at Week 26 until Week 52 (placebo/sitagliptin arm). Sitagliptin will be given with protocol-specified doses of metformin immediate release.

Placebo/Sitagliptin; Sitagliptin 100 mg

Metformin immediate release DRUG

The patient's stable dose of metformin immediate release background therapy should be continued throughout the study.

Canagliflozin 100 mg; Canagliflozin 300 mg; Placebo/Sitagliptin; Sitagliptin 100 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have a diagnosis of T2DM and be currently treated with metformin IR
• Patients in the study must have a HbA1c between \>=7 and \<=10.5%
• Patients must have a fasting plasma glucose (FPG) \<270 mg/dL (15 mmol/L)

You may not qualify if:

• History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (125)

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Little Rock, Arkansas, United States

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Fountain Valley, California, United States

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National City, California, United States

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Northridge, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Bradenton, Florida, United States

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Brooksville, Florida, United States

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DeFuniak Springs, Florida, United States

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Hialeah, Florida, United States

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Niceville, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Savannah, Georgia, United States

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Champaign, Illinois, United States

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Avon, Indiana, United States

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Fishers, Indiana, United States

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Franklin, Indiana, United States

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West Des Moines, Iowa, United States

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Wichita, Kansas, United States

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Munfordville, Kentucky, United States

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Portland, Maine, United States

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Benzonia, Michigan, United States

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Interlochen, Michigan, United States

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Troy, Michigan, United States

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Picayune, Mississippi, United States

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Florissant, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Mansfield, New Jersey, United States

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New Hyde Park, New York, United States

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Asheboro, North Carolina, United States

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Charlotte, North Carolina, United States

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Kettering, Ohio, United States

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Oregon City, Oregon, United States

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Altoona, Pennsylvania, United States

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Tipton, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Greer, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Nashville, Tennessee, United States

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New Braunfels, Texas, United States

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San Antonio, Texas, United States

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Bountiful, Utah, United States

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Spokane, Washington, United States

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Buenos Aires, Argentina

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Mendoza, Argentina

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San Juan, Argentina

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Sevlievo, Bulgaria

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Sofia, Bulgaria

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Barranquilla, Colombia

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Bogotá, Colombia

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Medellín, Colombia

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Beroun, Czechia

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Pardubice, Czechia

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Pilsen, Czechia

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Rychnov nad Kněžnou, Czechia

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Tábor, Czechia

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Tallinn, Estonia

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Piraeus, Greece

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Thessalonikis, Greece

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Ahmedabad, Gujarat, India

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Aurangabad, India

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Bangalore, India

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Bangalore, Karnataka, India

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Belagavi, India

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Coimbatore, India

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Mumbai, India

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Nagpur, India

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Pune, India

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Trivandrum, India

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Daugavpils, Latvia

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Limbaži, Latvia

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Riga, Latvia

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Talsi, Latvia

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Kelantan, Malaysia

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Kuala Lumpur, Malaysia

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Kuala Selangor, Malaysia

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Pulau Pinang, Malaysia

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Culiacán, Mexico

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Guadalajara, Mexico

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Monterrey, Mexico

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Querétaro, Mexico

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Tampico, Mexico

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Lima 1 Lima Lima, Peru

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Lodz, Poland

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Lublin, Poland

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Wroclaw, Poland

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Zgierz, Poland

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Łęczyca, Poland

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Aveiro, Portugal

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Leiria, Portugal

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Lisbon, Portugal

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Portalegre, Portugal

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San Juan, Puerto Rico

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Chelyabinsk, Russia

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Dzerzhinsky Moscow Region, Russia

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Kemerovo, Russia

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Penza, Russia

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Saint Petersburg, Russia

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Yekaterinburg, Russia

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Singapore, Singapore

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Banská Bystrica, Slovakia

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Bratislava, Slovakia

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Košice, Slovakia

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Šahy, Slovakia

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Trebišov, Slovakia

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Gothenburg, Sweden

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Stockholm, Sweden

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Bangkok, Thailand

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Chiang Mai, Thailand

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Khon Kaen, Thailand

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Ankara, Turkey (Türkiye)

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Antalya, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Konya, Turkey (Türkiye)

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Donetsk, Ukraine

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Ivano-Frankivsk, Ukraine

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Kiev, Ukraine

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Sumy, Ukraine

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Vinnitsa, Ukraine

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Zaporizhzhya, Ukraine

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Related Publications (19)

• Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.

  PMID: 29313267 DERIVED

• Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.

  PMID: 28327140 DERIVED

• Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.

  PMID: 28241822 DERIVED

• Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.

  PMID: 28197834 DERIVED

• Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.

  PMID: 27977934 DERIVED

• John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.

  PMID: 27600862 DERIVED

• Schernthaner G, Lavalle-Gonzalez FJ, Davidson JA, Jodon H, Vijapurkar U, Qiu R, Canovatchel W. Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes. Postgrad Med. 2016 Nov;128(8):725-730. doi: 10.1080/00325481.2016.1210988. Epub 2016 Jul 26.

  PMID: 27391951 DERIVED

• Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

  PMID: 26580237 DERIVED

• Lavalle-Gonzalez FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.

  PMID: 26579834 DERIVED

• Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015 Nov;31(11):1993-2000. doi: 10.1185/03007995.2015.1082991. Epub 2015 Sep 28.

  PMID: 26373629 DERIVED

• Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.

  PMID: 26121561 DERIVED

• Cefalu WT, Stenlof K, Leiter LA, Wilding JP, Blonde L, Polidori D, Xie J, Sullivan D, Usiskin K, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia. 2015 Jun;58(6):1183-7. doi: 10.1007/s00125-015-3547-2. Epub 2015 Mar 27.

  PMID: 25813214 DERIVED

• Bailey RA, Vijapurkar U, Meininger G, Rupnow MF, Blonde L. Diabetes-Related Composite Quality End Point Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Analysis of 2 Clinical Trials. Clin Ther. 2015 May 1;37(5):1045-54. doi: 10.1016/j.clinthera.2015.02.020. Epub 2015 Mar 18.

  PMID: 25795432 DERIVED

• Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, Kline I, Fung A, Meininger G. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2014 Dec;16(12):875-82. doi: 10.1111/jch.12425. Epub 2014 Oct 20.

  PMID: 25329038 DERIVED

• Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med. 2014 May;126(3):16-34. doi: 10.3810/pgm.2014.05.2753.

  PMID: 24918789 DERIVED

• Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.

  PMID: 24786834 DERIVED

• Sinclair A, Bode B, Harris S, Vijapurkar U, Mayer C, Fung A, Shaw W, Usiskin K, Desai M, Meininger G. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.

  PMID: 24742013 DERIVED

• Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.

  PMID: 24517339 DERIVED

• Lavalle-Gonzalez FJ, Januszewicz A, Davidson J, Tong C, Qiu R, Canovatchel W, Meininger G. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013 Dec;56(12):2582-92. doi: 10.1007/s00125-013-3039-1. Epub 2013 Sep 13.

  PMID: 24026211 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Canagliflozin; Sitagliptin Phosphate; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Triazoles; Azoles; Pyrazines; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
• Organization: Janssen Research & Development, LLC

1 800 526 7736

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 20, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: May 1, 2012
• Last Updated: July 30, 2013
• Results First Posted: July 30, 2013

Record last verified: 2013-07

Locations

US (45); CZ (5); PR (1); SE (2); MY (4); TH (3); ME (5); AR (3); BU (4); LA (4); SG (1); PT (4); SL (5); TU (5); GR (2); CO (3); RU (6); UA (6); ES (1); IN (10); PE (1); PL (5)