An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

NCT01064414 | Completed Phase 3 Results DMC

• 2 other identifiers: CR01700828431754DIA3004
• Study Type: interventional
• Target: 272
• Locations: 18 countries
• Sites: 106

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have reduced kidney function.

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency

Keywords

Canagliflozin; JNJ 28431754; Placebo; Sodium-Glucose Transporter 2; hemoglobin A1c protein, Blood Glucose; reduced kidney function, Type 2 diabetes mellitus

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 group minus placebo) in the LS mean change.

  Day 1 (Baseline) and Week 26

Secondary Outcomes (2)

• 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

Study Arms (3)

Canagliflozin 100 mg

EXPERIMENTAL

Each patient will receive 100 mg of canagliflozin once daily for 52 weeks.

Drug: Canagliflozin

Canagliflozin 300 mg

EXPERIMENTAL

Each patient will receive 300 mg of canagliflozin once daily for 52 weeks.

Drug: Canagliflozin

Placebo

PLACEBO COMPARATOR

Each patient will receive matching placebo once daily for 52 weeks.

Drug: Placebo

Interventions

Canagliflozin DRUG

One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information

Canagliflozin 100 mg; Canagliflozin 300 mg

Placebo DRUG

One matching placebo capsule orally once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information

Placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with T2DM not on an AHA or on any AHA in monotherapy or combination therapy (including oral or non oral agents)
• Patients with reduced kidney function

You may not qualify if:

• History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
• Have proliferative diabetic retinopathy for which treatment is planned during the course of the study
• Kidney disease that required treatment with immunosuppressive therapy, history of dialysis or kidney transplant, presence of nephrotic syndrome (eg, severe proteinuria with hypoalbuminemia and/or edema), or inflammatory kidney disease
• Receiving anti hypertensive or anti-hyperlipidemic therapy not on a stable regimen
• History of a severe hypoglycemic episode within 6 months before screening

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (106)

Unknown Facility

Concord, California, United States

Location

Unknown Facility

Fountain Valley, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Pembroke Pines, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

West Palm Beach, Florida, United States

Location

Unknown Facility

Augusta, Georgia, United States

Location

Unknown Facility

Nampa, Idaho, United States

Location

Unknown Facility

Baton Rouge, Louisiana, United States

Location

Unknown Facility

Jackson, Mississippi, United States

Location

Unknown Facility

Picayune, Mississippi, United States

Location

Unknown Facility

Chesterfield, Missouri, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Canal Fulton, Ohio, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Zanesville, Ohio, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Meridian, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

North Charleston, South Carolina, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Fairfax, Virginia, United States

Location

Unknown Facility

Camperdown, Australia

Location

Unknown Facility

Gosford, Australia

Location

Unknown Facility

Parkville, Australia

Location

Unknown Facility

Reservoir, Australia

Location

Unknown Facility

Aalst, Belgium

Location

Unknown Facility

Bonheiden, Belgium

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Liège, Belgium

Location

Unknown Facility

Sint-Niklaas, Belgium

Location

Unknown Facility

Turnhout, Belgium

Location

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Victoria, British Columbia, Canada

Location

Unknown Facility

Antigonish, Nova Scotia, Canada

Location

Unknown Facility

Sydney, Nova Scotia, Canada

Location

Unknown Facility

Hamilton, Ontario, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Smiths Falls, Ontario, Canada

Location

Unknown Facility

Thornhill, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Calgary, Canada

Location

Unknown Facility

Corbeil-Essonnes, France

Location

Unknown Facility

La Rochelle Cedex 1 Poitou-Cha, France

Location

Unknown Facility

Le Creusot, France

Location

Unknown Facility

Nantes, France

Location

Unknown Facility

Pierre-Bénite, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, France

Location

Unknown Facility

Vénissieux, France

Location

Unknown Facility

Dormagen, Germany

Location

Unknown Facility

Dortmund, Germany

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Einbeck, Germany

Location

Unknown Facility

Freiburg im Breisgau, Germany

Location

Unknown Facility

Kassel, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Schkeuditz, Germany

Location

Unknown Facility

Würzburg, Germany

Location

Unknown Facility

Aurangabad, India

Location

Unknown Facility

Madurai, India

Location

Unknown Facility

Pune, India

Location

Unknown Facility

Daugavpils, Latvia

Location

Unknown Facility

Ogre, Latvia

Location

Unknown Facility

Riga, Latvia

Location

Unknown Facility

Jalan Cheras N/A, Malaysia

Location

Unknown Facility

Kajang, Malaysia

Location

Unknown Facility

Kuala Lumpur, Malaysia

Location

Unknown Facility

Pulau Pinang, Malaysia

Location

Unknown Facility

Aguascalientes, Mexico

Location

Unknown Facility

Culiacán, Mexico

Location

Unknown Facility

Morelia, Mexico

Location

Unknown Facility

Zapopan, Mexico

Location

Unknown Facility

Auckland, New Zealand

Location

Unknown Facility

Christchurch, New Zealand

Location

Unknown Facility

Dunedin Nz, New Zealand

Location

Unknown Facility

Nz, New Zealand

Location

Unknown Facility

Lublin, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Łask, Poland

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Târgovişte, Romania

Location

Unknown Facility

Chelyabinsk, Russia

Location

Unknown Facility

Kirov, Russia

Location

Unknown Facility

Kursk, Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Nizhny Novgorod, Russia

Location

Unknown Facility

Petrozavodsk, Russia

Location

Unknown Facility

Rostov-on-Don, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Yaroslavl, Russia

Location

Unknown Facility

Parow, Cape Town, South Africa

Location

Unknown Facility

Pretoria, South Africa

Location

Unknown Facility

Somerset West, South Africa

Location

Unknown Facility

Seognam-Si, Kyungki-Do, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Ciudad Real, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

San Sebastián de los Reyes, Spain

Location

Unknown Facility

Santa Cruz de Tenerife, Spain

Location

Unknown Facility

Valencia, Spain

Location

Related Publications (3)

• 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

• 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

• 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

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 C. 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 8, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: August 1, 2012
• Last Updated: August 14, 2013
• Results First Posted: May 27, 2013

Record last verified: 2013-08

Locations

ES (6); BE (6); CA (10); DE (9); ME (4); AU (4); PL (3); KR (2); US (26); ZA (3); IN (3); MY (4); LA (3); RU (9); RO (2); BR (1); NZ (4); FR (7)