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
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Condition or disease | Intervention/treatment | Phase |
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Obesity | Drug: Canagliflozin Drug: Phentermine Drug: Matching Placebo to Canagliflozin Drug: Matching Placebo to Phentermine | Phase 2 |
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 |
Arm | Intervention/treatment |
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Experimental: Canagliflozin + Phentermine
300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.
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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.
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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.
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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. |
- 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.
- 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.
- 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.
- 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.
- 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.
- Change From Baseline in Pulse Rate at Week 26 [ Time Frame: Week 26 ]Change from baseline in pulse rate at week 26
- 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.

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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 |
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

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
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 |
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
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 |
Obesity Overweight Canagliflozin Phentermine INVOKANA® |
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 |