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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Canagliflozin; Drug: Phentermine; Drug: Matching Placebo to Phentermine; Drug: Matching Placebo to Canagliflozin

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).

• Study Type: Interventional
• Enrollment (Actual): 335
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States
  • California
    • Walnut Creek, California, United States
  • Florida
    • Jacksonville, Florida, United States
  • Idaho
    • Meridian, Idaho, United States
  • Indiana
    • Evansville, Indiana, United States
  • Kentucky
    • Lexington, Kentucky, United States
    • Louisville, Kentucky, United States
  • Louisiana
    • New Orleans, Louisiana, United States
  • Massachusetts
    • Milford, Massachusetts, United States
  • New York
    • Manlius, New York, United States
  • Rhode Island
    • Warwick, Rhode Island, United States
  • South Carolina
    • Mt Pleasant, South Carolina, United States
  • Tennessee
    • Nashville, Tennessee, United States
  • Texas
    • Dallas, Texas, United States
    • Odessa, Texas, United States
  • Virginia
    • Norfolk, Virginia, United States
  • Wisconsin
    • Wauwatosa, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Canagliflozin + Phentermine; 300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.	Drug: Canagliflozin; 300 mg capsule, taken once daily, orally for 26 weeks.; Other Names: INVOKANA; Drug: Phentermine; 15 mg capsule, taken once daily, orally for 26 weeks.
Experimental: Canagliflozin + Placebo (Phentermine); 300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.	Drug: Canagliflozin; 300 mg capsule, taken once daily, orally for 26 weeks.; Other Names: INVOKANA; Drug: Matching Placebo to Phentermine; Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.
Experimental: Phentermine + Placebo (Canagliflozin); 15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.	Drug: Phentermine; 15 mg capsule, taken once daily, orally for 26 weeks.; Drug: Matching Placebo to Canagliflozin; Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.
Placebo Comparator: Placebo; Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.	Drug: Matching Placebo to Phentermine; Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.; Drug: Matching Placebo to Canagliflozin; Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 26
Change From Baseline in Systolic Blood Pressure at Week 26	Change from baseline in systolic blood pressure was analysed at week 26.	Week 26
Absolute Change From Baseline in Body Weight at Week 26	Absolute change from baseline in body weight was analysed at week 26.	Week 26

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26	Change from baseline in diastolic blood pressure (DBP) at week 26.	Week 26
Change From Baseline in Pulse Rate at 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	Percentage of participants with weight loss >= 10 percent at week 26.	Week 26

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 17, 2014

Study Record Updates

• Last Update Posted (Estimate): October 6, 2016
• Last Update Submitted That Met QC Criteria: August 10, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Canagliflozin; Phentermine; INVOKANA®
• Additional Relevant MeSH Terms: Body Weight; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Appetite Depressants; Anti-Obesity Agents; Sodium-Glucose Transporter 2 Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Canagliflozin; Phentermine
• Other Study ID Numbers: CR103086; 28431754OBE2002 (Other Identifier: Janssen Research & Development, LLC)