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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243202
• Other study ID #: CR103086
• Secondary ID: 28431754OBE2002
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2014
• Last updated: August 7, 2015
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Canagliflozin
300 mg capsule, taken once daily, orally for 26 weeks.
• Phentermine
15 mg capsule, taken once daily, orally for 26 weeks.
• Matching Placebo to Canagliflozin
Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.
• Matching Placebo to Phentermine
Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from Baseline in body weight at Week 26		Baseline, Week 26	No
Secondary	Percentage of participants who lose at least 5% of their initial body weight		Baseline, Week 26	No
Secondary	Absolute change from Baseline in systolic blood pressure (SBP) at Week 26		Baseline, Week 26	No
Secondary	Absolute change from baseline in body weight at Week 26		Baseline, Week 26	No
Secondary	Change From Baseline in Pulse Rate at Week 26		Baseline, Week 26	Yes