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A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin

Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Canagliflozin, 100 mg (Drug); Canagliflozin, 300 mg (Drug); Placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Janssen Research & Development, LLC

Official(s) and/or principal investigator(s):
Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC

Summary

The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.

Clinical Details

Official title: A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin Therapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change from baseline in glycosylated hemoglobin (HbA1c)

Evaluation of safety and tolerability of canagliflozin by monitoring the Adverse Events

Secondary outcome:

Change from baseline in fasting plasma glucose (FPG)

Change from baseline in percentage of body weight

Proportions of patients with HbA1c <7.0%

Change from baseline in systolic blood pressure (SBP)

Detailed description: This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a study drug, to test whether the study drug has a real effect), multicenter study of efficacy, safety, and tolerability of canagliflozin in participants with T2DM, who have inadequate glycemic (blood sugar) control on maximally or near-maximally effective doses of metformin >=1500 mg/day and sitagliptin 100 mg/day. Approximately 200 participants will be randomly assigned to 1 of 2 treatment groups in 1: 1 ratio for 26 weeks. During the study the participants will be also provided with diet and exercise counseling (standardized non-pharmacological therapy).

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must have a diagnosis of type 2 diabetes mellitus

- Must have a screening HbA1c of >=7. 5% to <=10. 5%

- Must be on metformin >=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed

dose combination) at a stable dose for at least 12 weeks before screening Exclusion Criteria:

- History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption

or primary renal glycosuria

- A myocardial infarction, unstable angina, revascularization procedure or

cerebrovascular accident within 12 weeks before screening

- eGFR <60 ml/min/1. 73m2, or serum creatinine >=1. 4 mg/dL for men and >=1. 3 mg/dL for

women

- Known significant liver disease (eg, acute hepatitis, chronic active hepatitis,

cirrhosis)

- Major surgery (ie, requiring general anesthesia) within 12 weeks before screening

Locations and Contacts

Coffs Harbour, Australia

Freemantle, Australia

Geelong, Australia

Heidelberg, Australia

Herston, Australia

Melbourne, Australia

Merewether, Australia

Sherwood, Australia

Sydney, Australia

Wollongong, Australia

La Rochelle Cedex 1 Poitou-Cha, France

La Tronche, France

Nancy, France

Narbonne Cedex, France

Nice Cedex 3, France

Paris Cedex 15, France

Venissieux, France

Freiburg, Germany

Fulda, Germany

Hamburg, Germany

Münster, Germany

Neuwied, Germany

Pirna, Germany

Speyer, Germany

Montgomery, Alabama, United States

Phoenix, Arizona, United States

Little Rock, Arkansas, United States

Northridge, California, United States

Norwalk, California, United States

Rancho Cucamonga, California, United States

San Ramon, California, United States

Aurora, Colorado, United States

Denver, Colorado, United States

Littleton, Colorado, United States

Cooper City, Florida, United States

Miami, Florida, United States

North Miami Beach, Florida, United States

Atlanta, Georgia, United States

Perry, Georgia, United States

Shawnee Mission, Kansas, United States

Marrero, Louisiana, United States

Metairie, Louisiana, United States

Metarie, Louisiana, United States

Rockville, Maryland, United States

Jackson, Mississippi, United States

Picayune, Mississippi, United States

Saint Louis, Missouri, United States

Nashua, New Hampshire, United States

Albuquerque, New Mexico, United States

Albany, New York, United States

Brampton, Ontario, Canada

Hawkesbury, Ontario, Canada

Toronto, Ontario, Canada

Arlington, Texas, United States

San Antonio, Texas, United States

Sugarland, Texas, United States

Bountiful, Utah, United States

Additional Information

Starting date: February 2014
Last updated: August 20, 2015

Page last updated: August 23, 2015

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