Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Efficacy of the Co-administration of Canagliflozin 300 mg and Phentermine 15 mg Compared With Placebo for the Treatment of Non-diabetic Overweight and Obese Subjects
2 other identifiers
interventional
335
1 country
17
Brief Summary
The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Sep 2014
Shorter than P25 for phase_2 obesity
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 16, 2014
CompletedFirst Posted
Study publicly available on registry
September 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
October 6, 2016
CompletedOctober 6, 2016
August 1, 2016
9 months
September 16, 2014
June 16, 2016
August 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Body Weight at Week 26
The percent change from baseline in body weight at Week 26 was analysed.
Week 26
Secondary Outcomes (3)
Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26
Week 26
Change From Baseline in Systolic Blood Pressure at Week 26
Week 26
Absolute Change From Baseline in Body Weight at Week 26
Week 26
Other Outcomes (3)
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
Week 26
Change From Baseline in Pulse Rate at Week 26
Week 26
Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26
Week 26
Study Arms (4)
Canagliflozin + Phentermine
EXPERIMENTAL300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.
Canagliflozin + Placebo (Phentermine)
EXPERIMENTAL300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.
Phentermine + Placebo (Canagliflozin)
EXPERIMENTAL15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.
Placebo
PLACEBO COMPARATORMatching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.
Interventions
300 mg capsule, taken once daily, orally for 26 weeks.
15 mg capsule, taken once daily, orally for 26 weeks.
Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.
Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.
Eligibility Criteria
You may qualify if:
- Must have BMI \>=30 kg/m2 and \<50 kg/m2 at screening or BMI \>=27 kg/m2 and \<50 kg/m2 at screening in the presence of a comorbidity of hypertension and/or dyslipidemia
- Must have stable weight, ie, change of \< =5% in the 3 months before screening
- Must agree to utilize a highly effective method of birth control
You may not qualify if:
- An established diagnosis of diabetes mellitus
- Has a history of obesity with a known secondary cause (eg, Cushing's disease/syndrome)
- Has a history of hereditary glucose-galactose malabsorption or primary renal glycosuria
- Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 12 weeks before screening
- Has an Glycated hemoglobin (HBA1c) greater than or equal (\>=) to 65 percent
- An average of 3 seated blood pressure (BP) readings of systolic BP \>= 160 mm Hg and/or Diastolic BP \>= 100 millimeters of mercury at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Meridian, Idaho, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Milford, Massachusetts, United States
Unknown Facility
Manlius, New York, United States
Unknown Facility
Warwick, Rhode Island, United States
Unknown Facility
Mt. Pleasant, South Carolina, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Odessa, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Wauwatosa, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Leader
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2014
First Posted
September 17, 2014
Study Start
September 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
October 6, 2016
Results First Posted
October 6, 2016
Record last verified: 2016-08