Clinical trial NCT02243202: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity
Overweight
Canagliflozin
Phentermine
INVOKANA®
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Percent Change From Baseline in Body Weight at Week 26
timeFrame: Week 26
Secondary outcomes:
measure: Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26
timeFrame: Week 26
measure: Change From Baseline in Systolic Blood Pressure at Week 26
timeFrame: Week 26
measure: Absolute Change From Baseline in Body Weight at Week 26
timeFrame: Week 26
Other outcomes:
measure: Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
timeFrame: Week 26
measure: Change From Baseline in Pulse Rate at Week 26
timeFrame: Week 26
measure: Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26
timeFrame: Week 26
Locations:
city: Phoenix
country: United States
state: Arizona
city: Walnut Creek
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Meridian
country: United States
state: Idaho
city: Evansville
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Milford
country: United States
state: Massachusetts
city: Manlius
country: United States
state: New York
city: Warwick
country: United States
state: Rhode Island
city: Mt Pleasant
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Wauwatosa
country: United States
state: Wisconsin
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: