Back to resultsEffects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
Primary Purpose
Obesity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Canagliflozin
Phentermine
Matching Placebo to Canagliflozin
Matching Placebo to Phentermine
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight, Canagliflozin, Phentermine, INVOKANA®
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Canagliflozin + Phentermine
Canagliflozin + Placebo (Phentermine)
Phentermine + Placebo (Canagliflozin)
Placebo
Arm Description
300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.
300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.
15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.
Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Body Weight at Week 26
The percent change from baseline in body weight at Week 26 was analysed.
Secondary Outcome Measures
Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26
Percentage of participants with weight loss >= 5 percent were analysed at week 26.
Change From Baseline in Systolic Blood Pressure at Week 26
Change from baseline in systolic blood pressure was analysed at week 26.
Absolute Change From Baseline in Body Weight at Week 26
Absolute change from baseline in body weight was analysed at week 26.
Full Information
NCT ID
NCT02243202
First Posted
September 16, 2014
Last Updated
August 10, 2016
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02243202
Brief Title
Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 medication to test whether the medication has a real effect), parallel-group, multicenter study of the effects of canagliflozin and phentermine co-administration in non-diabetic overweight or obese participants. The study will be conducted for about 33 weeks, approximately 344 participants will be randomly assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo. All participants will be also provided with diet and exercise counseling for weight loss (standardized non-pharmacological therapy).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Overweight, Canagliflozin, Phentermine, INVOKANA®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
335 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Canagliflozin + Phentermine
Arm Type
Experimental
Arm Description
300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.
Arm Title
Canagliflozin + Placebo (Phentermine)
Arm Type
Experimental
Arm Description
300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.
Arm Title
Phentermine + Placebo (Canagliflozin)
Arm Type
Experimental
Arm Description
15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.
Intervention Type
Drug
Intervention Name(s)
Canagliflozin
Other Intervention Name(s)
INVOKANA
Intervention Description
300 mg capsule, taken once daily, orally for 26 weeks.
Intervention Type
Drug
Intervention Name(s)
Phentermine
Intervention Description
15 mg capsule, taken once daily, orally for 26 weeks.
Intervention Type
Drug
Intervention Name(s)
Matching Placebo to Canagliflozin
Intervention Description
Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.
Intervention Type
Drug
Intervention Name(s)
Matching Placebo to Phentermine
Intervention Description
Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Body Weight at Week 26
Description
The percent change from baseline in body weight at Week 26 was analysed.
Time Frame
Week 26
Secondary Outcome Measure Information:
Title
Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26
Description
Percentage of participants with weight loss >= 5 percent were analysed at week 26.
Time Frame
Week 26
Title
Change From Baseline in Systolic Blood Pressure at Week 26
Description
Change from baseline in systolic blood pressure was analysed at week 26.
Time Frame
Week 26
Title
Absolute Change From Baseline in Body Weight at Week 26
Description
Absolute change from baseline in body weight was analysed at week 26.
Time Frame
Week 26
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
Description
Change from baseline in diastolic blood pressure (DBP) at week 26.
Time Frame
Week 26
Title
Change From Baseline in Pulse Rate at Week 26
Description
Change from baseline in pulse rate at week 26
Time Frame
Week 26
Title
Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26
Description
Percentage of participants with weight loss >= 10 percent at week 26.
Time Frame
Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Walnut Creek
State/Province
California
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Meridian
State/Province
Idaho
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Milford
State/Province
Massachusetts
Country
United States
City
Manlius
State/Province
New York
Country
United States
City
Warwick
State/Province
Rhode Island
Country
United States
City
Mt Pleasant
State/Province
South Carolina
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Odessa
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Wauwatosa
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
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