Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants

NCT ID: NCT02243202

Last Updated: 2016-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 335 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-06-30

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).

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Canagliflozin + Phentermine

300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.

Group Type: EXPERIMENTAL

Canagliflozin

Intervention Type: DRUG

300 mg capsule, taken once daily, orally for 26 weeks.

Phentermine

Intervention Type: DRUG

15 mg capsule, taken once daily, orally for 26 weeks.

Canagliflozin + Placebo (Phentermine)

300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.

Group Type: EXPERIMENTAL

Canagliflozin

Intervention Type: DRUG

300 mg capsule, taken once daily, orally for 26 weeks.

Matching Placebo to Phentermine

Intervention Type: DRUG

Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.

Phentermine + Placebo (Canagliflozin)

15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.

Group Type: EXPERIMENTAL

Phentermine

Intervention Type: DRUG

15 mg capsule, taken once daily, orally for 26 weeks.

Matching Placebo to Canagliflozin

Intervention Type: DRUG

Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.

Placebo

Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.

Group Type: PLACEBO_COMPARATOR

Matching Placebo to Canagliflozin

Intervention Type: DRUG

Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.

Matching Placebo to Phentermine

Intervention Type: DRUG

Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.

Interventions

Canagliflozin

300 mg capsule, taken once daily, orally for 26 weeks.

Intervention Type: DRUG

Phentermine

15 mg capsule, taken once daily, orally for 26 weeks.

Intervention Type: DRUG

Matching Placebo to Canagliflozin

Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.

Intervention Type: DRUG

Matching Placebo to Phentermine

Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.

Intervention Type: DRUG

Other Intervention Names

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Phoenix, Arizona, United States

Walnut Creek, California, United States

Jacksonville, Florida, United States

Meridian, Idaho, United States

Evansville, Indiana, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

New Orleans, Louisiana, United States

Milford, Massachusetts, United States

Manlius, New York, United States

Warwick, Rhode Island, United States

Mt. Pleasant, South Carolina, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Odessa, Texas, United States

Norfolk, Virginia, United States

Wauwatosa, Wisconsin, United States

Countries

United States

Other Identifiers

28431754OBE2002

Identifier Type: OTHER

Identifier Source: secondary_id

CR103086

Identifier Type: -

Identifier Source: org_study_id