A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus

NCT01106651 | Completed Phase 3 Results DMC

• 2 other identifiers: CR01701428431754DIA3010
• Study Type: interventional
• Target: 716
• Locations: 17 countries
• Sites: 86

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.

Conditions

Diabetes Mellitus, Type 2

Keywords

Canagliflozin; Placebo; Hemoglobin A1c; Bone; 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 (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

• Percent Change in Body Weight From Baseline to Week 26

  Day 1 (Baseline) and Week 26

• Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition

  Day 1 (Baseline) and Week 26

• Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition

  Day 1 (Baseline) and Week 26

Study Arms (3)

Canagliflozin 100 mg

EXPERIMENTAL

Each patient will receive 100 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Drug: Canagliflozin 100 mg; Drug: Antihyperglycemic agent(s)

Canagliflozin 300 mg

EXPERIMENTAL

Each patient will receive 300 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Drug: Canagliflozin 300 mg; Drug: Antihyperglycemic agent(s)

Placebo

PLACEBO COMPARATOR

Each patient will receive matching placebo once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Drug: Antihyperglycemic agent(s); Drug: Placebo

Interventions

Canagliflozin 100 mg DRUG

One 100 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Canagliflozin 100 mg

Canagliflozin 300 mg DRUG

One 300 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Canagliflozin 300 mg

Antihyperglycemic agent(s) DRUG

Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 \[DPP-4\] inhibitors, metformin, insulin \[all types\]) and their combinations (sulfonylurea agent and insulin \[all types\], metformin and insulin \[all types\], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 \[DPP-4\]) are used as per protocol specifications.

Canagliflozin 100 mg; Canagliflozin 300 mg; Placebo

Placebo DRUG

One matching placebo capsule orally once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Placebo

Eligibility Criteria

• Age: 55 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 may be currently treated with a stable regimen of antihyperglycemic agent(s)
• Patients in the study must have a HbA1c between \>=7 and \<=10.0%
• 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, or 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 (86)

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Carmichael, California, United States

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Citrus Heights, California, United States

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Fair Oaks, California, United States

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Roseville, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Walnut Creek, California, United States

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Daytona Beach, Florida, United States

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Fleming Island, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Wichita, Kansas, United States

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Waltham, Massachusetts, United States

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Pahrump, Nevada, United States

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Albuquerque, New Mexico, United States

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Cary, North Carolina, United States

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Charlotte, North Carolina, United States

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Wilmington, North Carolina, United States

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Bismarck, North Dakota, United States

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Franklin, Ohio, United States

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Mt. Pleasant, South Carolina, United States

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Bristol, Tennessee, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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Irving, Texas, United States

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Plano, Texas, United States

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Richardson, Texas, United States

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Renton, Washington, United States

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Tacoma, Washington, United States

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Wenatchee, Washington, United States

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Fremantle, Australia

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Heidelberg Heights, Australia

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Meadowbrook, Australia

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Richmond, Australia

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Vancouver, British Columbia, Canada

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St. John's, Newfoundland and Labrador, Canada

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Barrie, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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Oakville, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Barranquilla, Colombia

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Bogotá, Colombia

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Corbeil-Essonnes, France

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Paris, France

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Vénissieux, France

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Thessaloniki, Greece

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Thessalonikis, Greece

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Shatin, Hong Kong

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Bangalore, India

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Nagpur, India

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Pune, India

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Auckland, New Zealand

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Christchurch, New Zealand

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Tauranga, New Zealand

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Wellington, New Zealand

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Katowice, Poland

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Krakow, Poland

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Torun, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Bucharest, Romania

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Sibiu, Romania

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Pretoria, South Africa

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Granada, Spain

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Madrid, Spain

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Pozuelo de Alarcón, Spain

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Seville, Spain

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Gothenburg, Sweden

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Uppsala, Sweden

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Bruderholz, Switzerland

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Sankt Gallen, Switzerland

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Kharkiv, Ukraine

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Kiev, Ukraine

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Birmingham, United Kingdom

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Cardiff, United Kingdom

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Glasgow, United Kingdom

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Liverpool, United Kingdom

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Manchester, United Kingdom

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Reading, United Kingdom

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Salford, United Kingdom

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Related Publications (8)

• Januzzi JL Jr, Butler J, Jarolim P, Sattar N, Vijapurkar U, Desai M, Davies MJ. Effects of Canagliflozin on Cardiovascular Biomarkers in Older Adults With Type 2 Diabetes. J Am Coll Cardiol. 2017 Aug 8;70(6):704-712. doi: 10.1016/j.jacc.2017.06.016. Epub 2017 Jun 12.

  PMID: 28619659 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

• Blonde L, Stenlof K, Fung A, Xie J, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. Postgrad Med. 2016 May;128(4):371-80. doi: 10.1080/00325481.2016.1169894. Epub 2016 Apr 7.

  PMID: 27002421 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

• Bilezikian JP, Watts NB, Usiskin K, Polidori D, Fung A, Sullivan D, Rosenthal N. Evaluation of Bone Mineral Density and Bone Biomarkers in Patients With Type 2 Diabetes Treated With Canagliflozin. J Clin Endocrinol Metab. 2016 Jan;101(1):44-51. doi: 10.1210/jc.2015-1860. Epub 2015 Nov 18.

  PMID: 26580234 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

• Bode B, Stenlof K, Sullivan D, Fung A, Usiskin K. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract (1995). 2013 Apr;41(2):72-84. doi: 10.3810/hp.2013.04.1020.

  PMID: 23680739 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Canagliflozin

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

Results Point of Contact

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

ClinicalTrialDisclosure@its.jnj.com

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: June 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: May 1, 2013
• Last Updated: November 4, 2014
• Results First Posted: May 29, 2013

Record last verified: 2014-10

Locations

ZA (1); NZ (4); FR (3); IN (3); PL (5); CO (2); SE (2); GB (7); CH (2); UA (2); ES (4); HK (1); RO (2); CA (8); US (34); GR (2); AU (4)