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
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