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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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ClinicalTrials.gov Identifier: NCT02243202
Recruitment Status : Completed
First Posted : September 17, 2014
Results First Posted : October 6, 2016
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Canagliflozin Drug: Phentermine Drug: Matching Placebo to Canagliflozin Drug: Matching Placebo to Phentermine Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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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 Name: 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 Name: 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 Canagliflozin
Placebo capsules look like canagliflozin but do not contain any active drug, 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.


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in Body Weight at Week 26 [ Time Frame: Week 26 ]
    The percent change from baseline in body weight at Week 26 was analysed.


Secondary Outcome Measures :
  1. Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26 [ Time Frame: Week 26 ]
    Percentage of participants with weight loss >= 5 percent were analysed at week 26.

  2. Change From Baseline in Systolic Blood Pressure at Week 26 [ Time Frame: Week 26 ]
    Change from baseline in systolic blood pressure was analysed at week 26.

  3. Absolute Change From Baseline in Body Weight at Week 26 [ Time Frame: Week 26 ]
    Absolute change from baseline in body weight was analysed at week 26.


Other Outcome Measures:
  1. Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26 [ Time Frame: Week 26 ]
    Change from baseline in diastolic blood pressure (DBP) at week 26.

  2. Change From Baseline in Pulse Rate at Week 26 [ Time Frame: Week 26 ]
    Change from baseline in pulse rate at week 26

  3. Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26 [ Time Frame: Week 26 ]
    Percentage of participants with weight loss >= 10 percent at week 26.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243202


Locations
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United States, Arizona
Phoenix, Arizona, United States
United States, California
Walnut Creek, California, United States
United States, Florida
Jacksonville, Florida, United States
United States, Idaho
Meridian, Idaho, United States
United States, Indiana
Evansville, Indiana, United States
United States, Kentucky
Lexington, Kentucky, United States
Louisville, Kentucky, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Massachusetts
Milford, Massachusetts, United States
United States, New York
Manlius, New York, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, South Carolina
Mt Pleasant, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Odessa, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
United States, Wisconsin
Wauwatosa, Wisconsin, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02243202    
Other Study ID Numbers: CR103086
28431754OBE2002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: September 17, 2014    Key Record Dates
Results First Posted: October 6, 2016
Last Update Posted: October 6, 2016
Last Verified: August 2016
Keywords provided by Janssen Research & Development, LLC:
Obesity
Overweight
Canagliflozin
Phentermine
INVOKANA®
Additional relevant MeSH terms:
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Canagliflozin
Overweight
Body Weight
Phentermine
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
 Central Nervous System Stimulants
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents