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

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02243202
• Collaborator: (none)
• Enrollment: 335
• Locations: 17
• Arms: 4
• Duration (Months): 9
• Patients Per Site: 19.7
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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

• Study Type: Interventional
• 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: Sep 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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 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

Primary Outcome Measures

1. Percent Change From Baseline in Body Weight at Week 26 [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 [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 [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 [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 [Week 26]

   Change from baseline in diastolic blood pressure (DBP) at week 26.

2. Change From Baseline in Pulse Rate at Week 26 [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 [Week 26]

   Percentage of participants with weight loss >= 10 percent at week 26.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States
2		Walnut Creek	California	United States
3		Jacksonville	Florida	United States
4		Meridian	Idaho	United States
5		Evansville	Indiana	United States
6		Lexington	Kentucky	United States
7		Louisville	Kentucky	United States
8		New Orleans	Louisiana	United States
9		Milford	Massachusetts	United States
10		Manlius	New York	United States
11		Warwick	Rhode Island	United States
12		Mt Pleasant	South Carolina	United States
13		Nashville	Tennessee	United States
14		Dallas	Texas	United States
15		Odessa	Texas	United States
16		Norfolk	Virginia	United States
17		Wauwatosa	Wisconsin	United States

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT02243202
• Other Study ID Numbers: CR103086; 28431754OBE2002
• First Posted: Sep 17, 2014
• Last Update Posted: Oct 6, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by Janssen Research & Development, LLC: Obesity; Overweight; Canagliflozin; Phentermine; INVOKANA®
• Additional relevant MeSH terms: Overweight; Canagliflozin; Phentermine

Study Results

Participant Flow

Pre-assignment Detail	Between screening and randomisation, eligible subjects were included in a 4-week single-blind run-in period in which all subjects were placed on a hypocaloric diet.

Arm/Group Title	Placebo	Phentermine 15 mg	Canagliflozin 300 mg	Canagliflozin 300 mg/Phentermine 15 mg
Arm/Group Description	Participants received placebo tablets orally for 26 weeks.	Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.	Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.	Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
Period Title: Overall Study
STARTED	82	85	84	84
Treated	82	85	84	83
COMPLETED	57	60	53	61
NOT COMPLETED	25	25	31	23

Baseline Characteristics

Arm/Group Title	Placebo	Phentermine 15 mg	Canagliflozin 300 mg	Canagliflozin 300 mg/Phentermine 15 mg	Total
Arm/Group Description	Participants received placebo tablets orally for 26 weeks.	Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.	Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.	Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.	Total of all reporting groups
Overall Participants	82	85	84	83	334
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.8 (11.09)	46.4 (11.14)	45.2 (11.02)	46.3 (12.45)	45.7 (11.41)
Sex: Female, Male (Count of Participants)
Female	67 81.7%	69 81.2%	68 81%	69 83.1%	273 81.7%
Male	15 18.3%	16 18.8%	16 19%	14 16.9%	61 18.3%
Region of Enrollment (participants) [Number]
United States	82 100%	85 100%	84 100%	83 100%	334 100%
Baseline Weight (Kilogram [kg]) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilogram [kg]]	104.3 (18.16)	102.8 (17.89)	103.3 (19.14)	101.1 (18.07)	102.9 (18.28)
Baseline Body Mass Index (BMI) (kilogram per meter square [kg/m²]) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram per meter square [kg/m²]]	38 (5.2)	37 (5.4)	37.3 (4.68)	36.8 (5.36)	37.3 (5.16)
Baseline Systolic Blood Pressure (millimeters of mercury [mmHg]) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [millimeters of mercury [mmHg]]	122.5 (13.86)	123.0 (11.83)	124.5 (13.01)	124.8 (12.83)	123.7 (12.87)
Baseline Diastolic Blood Pressure (millimeters of mercury [mmHg]) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [millimeters of mercury [mmHg]]	78.8 (8.43)	78.1 (9.00)	80.2 (7.88)	79.4 (8.21)	79.1 (8.39)
Baseline Pulse Rate ((BEATS/MIN)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [(BEATS/MIN)]	73.5 (8.72)	70.7 (10.09)	71.5 (9.40)	72.4 (9.66)	72.0 (9.50)

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Body Weight at Week 26
Description	The percent change from baseline in body weight at Week 26 was analysed.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Phentermine 15 mg	Canagliflozin 300 mg	Canagliflozin 300 mg/Phentermine 15 mg
Arm/Group Description	Participants received placebo tablets orally for 26 weeks.	Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.	Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.	Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
Measure Participants	76	76	78	77
Least Squares Mean (Standard Error) [Percent Change]	-0.6 (0.6)	-4.1 (0.6)	-1.9 (0.6)	-7.5 (0.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Phentermine 15 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Model for Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-3.5
	Confidence Interval	(2-Sided) 95%; -5.3 to -1.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Canagliflozin 300 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.142
	Comments
	Method	Mixed Model for Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-1.3
	Confidence Interval	(2-Sided) 95%; -3.1 to 0.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Canagliflozin 300 mg/Phentermine 15 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Model for Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-6.9
	Confidence Interval	(2-Sided) 95%; -8.6 to -5.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26
Description	Percentage of participants with weight loss >= 5 percent were analysed at week 26.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Phentermine 15 mg	Canagliflozin 300 mg	Canagliflozin 300 mg/Phentermine 15 mg
Arm/Group Description	Participants received placebo tablets orally for 26 weeks.	Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.	Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.	Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
Measure Participants	57	60	56	63
Number [percentage of participants]	17.5 21.3%	41.7 49.1%	17.9 21.3%	66.7 80.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Phentermine 15 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Generalized linear Mixed Model
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.15
	Confidence Interval	(2-Sided) 95%; 1.70 to 10.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Canagliflozin 300 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.825
	Comments
	Method	Generalized linear Mixed Model
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95%; 0.41 to 3.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Canagliflozin 300 mg/Phentermine 15 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Generalized linear Mixed Model
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	10.20
	Confidence Interval	(2-Sided) 95%; 4.15 to 25.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Systolic Blood Pressure at Week 26
Description	Change from baseline in systolic blood pressure was analysed at week 26.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Phentermine 15 mg	Canagliflozin 300 mg	Canagliflozin 300 mg/Phentermine 15 mg
Arm/Group Description	Participants received placebo tablets orally for 26 weeks.	Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.	Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.	Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
Measure Participants	75	76	78	77
Least Squares Mean (Standard Error) [mmHg (millimeters of mercury)]	-2.7 (1.3)	-1.4 (1.2)	-3.1 (1.3)	-6.9 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Phentermine 15 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.456
	Comments
	Method	Mixed Model for Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -2.1 to 4.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.8
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Canagliflozin 300 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.827
	Comments
	Method	Mixed Model for Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -3.9 to 3.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.8
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Canagliflozin 300 mg/Phentermine 15 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.015
	Comments
	Method	Mixed Model for Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-4.2
	Confidence Interval	(2-Sided) 95%; -7.7 to -0.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7
	Estimation Comments

4. Secondary Outcome

Title	Absolute Change From Baseline in Body Weight at Week 26
Description	Absolute change from baseline in body weight was analysed at week 26.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Phentermine 15 mg	Canagliflozin 300 mg	Canagliflozin 300 mg/Phentermine 15 mg
Arm/Group Description	Participants received placebo tablets orally for 26 weeks.	Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.	Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.	Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
Measure Participants	76	76	78	77
Least Squares Mean (Standard Error) [Kilogram (Kg)]	-0.6 (0.6)	-4.1 (0.6)	-1.9 (0.7)	-7.3 (0.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Phentermine 15 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Model for Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-3.5
	Confidence Interval	(2-Sided) 95%; -5.3 to -1.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Canagliflozin 300 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.153
	Comments
	Method	Mixed Model for Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-1.3
	Confidence Interval	(2-Sided) 95%; -3.1 to 0.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Canagliflozin 300 mg/Phentermine 15 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Model for Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-6.7
	Confidence Interval	() 95%; -8.5 to -4.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9
	Estimation Comments

5. Other Pre-specified Outcome

Title	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
Description	Change from baseline in diastolic blood pressure (DBP) at week 26.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Phentermine 15 mg	Canagliflozin 300 mg	Canagliflozin 300 mg/Phentermine 15 mg
Arm/Group Description	Participants received placebo tablets orally for 26 weeks.	Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.	Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.	Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
Measure Participants	75	76	78	77
Least Squares Mean (Standard Error) [mmHg (millimeters of mercury)]	-0.9 (0.9)	0.1 (0.8)	-1.5 (0.9)	-2.5 (0.8)

6. Other Pre-specified Outcome

Title	Change From Baseline in Pulse Rate at Week 26
Description	Change from baseline in pulse rate at week 26
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	Phentermine 15 mg	Canagliflozin 300 mg	Canagliflozin 300 mg/Phentermine 15 mg
Arm/Group Description	Participants received placebo tablets orally for 26 weeks.	Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.	Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.	Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
Measure Participants	75	76	78	77
Least Squares Mean (Standard Error) [Beats Per Minute (Beats/Min)]	-0.7 (1.0)	4.1 (1.0)	0.7 (1.0)	3.5 (0.9)

7. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent.

Arm/Group Title	Placebo	Phentermine 15 mg	Canagliflozin 300 mg	Canagliflozin 300 mg/Phentermine 15 mg
Arm/Group Description	Participants received placebo tablets orally for 26 weeks.	Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.	Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.	Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
Measure Participants	82	85	84	83
Number [Percentage of Participants]	8.8 10.7%	8.3 9.8%	5.4 6.4%	34.9 42%

Adverse Events

Time Frame	Up to 33 weeks
Adverse Event Reporting Description	Only participants who had TEAE (Treatment-Emergent Adverse Event) in the table (i.e. meeting the pre-specified cut-off percentage) are included in the Total, other (not including serious) adverse events count.
Arm/Group Title	Placebo		Phentermine 15 mg		Canagliflozin 300 mg		Canagliflozin 300 mg/Phentermine 15 mg
Arm/Group Description	Participants received placebo tablets orally for 26 weeks.		Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.		Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.		Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
All Cause Mortality
	Placebo		Phentermine 15 mg		Canagliflozin 300 mg		Canagliflozin 300 mg/Phentermine 15 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Phentermine 15 mg		Canagliflozin 300 mg		Canagliflozin 300 mg/Phentermine 15 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		0/85 (0%)		0/84 (0%)		1/83 (1.2%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	0/82 (0%)		0/85 (0%)		0/84 (0%)		1/83 (1.2%)
Other (Not Including Serious) Adverse Events
	Placebo		Phentermine 15 mg		Canagliflozin 300 mg		Canagliflozin 300 mg/Phentermine 15 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/82 (50%)		37/85 (43.5%)		42/84 (50%)		42/83 (50.6%)
Cardiac disorders
Tachycardia	0/82 (0%)		0/85 (0%)		0/84 (0%)		2/83 (2.4%)
Gastrointestinal disorders
Abdominal Distension	2/82 (2.4%)		2/85 (2.4%)		0/84 (0%)		3/83 (3.6%)
Constipation	3/82 (3.7%)		11/85 (12.9%)		1/84 (1.2%)		6/83 (7.2%)
Diarrhoea	1/82 (1.2%)		2/85 (2.4%)		0/84 (0%)		0/83 (0%)
Dry Mouth	0/82 (0%)		2/85 (2.4%)		0/84 (0%)		5/83 (6%)
Dyspepsia	2/82 (2.4%)		1/85 (1.2%)		1/84 (1.2%)		2/83 (2.4%)
Nausea	0/82 (0%)		6/85 (7.1%)		7/84 (8.3%)		3/83 (3.6%)
Rectal Haemorrhage	0/82 (0%)		0/85 (0%)		2/84 (2.4%)		0/83 (0%)
General disorders
Fatigue	0/82 (0%)		2/85 (2.4%)		2/84 (2.4%)		0/83 (0%)
Immune system disorders
Hypersensitivity	0/82 (0%)		1/85 (1.2%)		2/84 (2.4%)		0/83 (0%)
Infections and infestations
Acute Sinusitis	2/82 (2.4%)		0/85 (0%)		2/84 (2.4%)		0/83 (0%)
Bronchitis	2/82 (2.4%)		5/85 (5.9%)		2/84 (2.4%)		1/83 (1.2%)
Conjunctivitis	0/82 (0%)		0/85 (0%)		2/84 (2.4%)		1/83 (1.2%)
Gastroenteritis	1/82 (1.2%)		0/85 (0%)		3/84 (3.6%)		3/83 (3.6%)
Influenza	1/82 (1.2%)		4/85 (4.7%)		0/84 (0%)		1/83 (1.2%)
Nasopharyngitis	4/82 (4.9%)		2/85 (2.4%)		2/84 (2.4%)		1/83 (1.2%)
Pharyngitis	0/82 (0%)		0/85 (0%)		0/84 (0%)		2/83 (2.4%)
Pharyngitis Streptococcal	1/82 (1.2%)		1/85 (1.2%)		4/84 (4.8%)		0/83 (0%)
Sinusitis	3/82 (3.7%)		1/85 (1.2%)		2/84 (2.4%)		3/83 (3.6%)
Tooth Infection	4/82 (4.9%)		1/85 (1.2%)		0/84 (0%)		2/83 (2.4%)
Upper Respiratory Tract Infection	15/82 (18.3%)		5/85 (5.9%)		11/84 (13.1%)		9/83 (10.8%)
Urinary Tract Infection	0/82 (0%)		1/85 (1.2%)		3/84 (3.6%)		2/83 (2.4%)
Viral Infection	0/82 (0%)		1/85 (1.2%)		2/84 (2.4%)		1/83 (1.2%)
Vulvovaginal Candidiasis	0/82 (0%)		0/85 (0%)		3/84 (3.6%)		0/83 (0%)
Vulvovaginal Mycotic Infection	0/82 (0%)		0/85 (0%)		4/84 (4.8%)		4/83 (4.8%)
Injury, poisoning and procedural complications
Fall	2/82 (2.4%)		0/85 (0%)		0/84 (0%)		0/83 (0%)
Muscle Strain	1/82 (1.2%)		1/85 (1.2%)		2/84 (2.4%)		1/83 (1.2%)
Investigations
Blood Creatine Phosphokinase Increased	1/82 (1.2%)		3/85 (3.5%)		1/84 (1.2%)		0/83 (0%)
Metabolism and nutrition disorders
Decreased Appetite	0/82 (0%)		2/85 (2.4%)		0/84 (0%)		1/83 (1.2%)
Polydipsia	0/82 (0%)		0/85 (0%)		0/84 (0%)		2/83 (2.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/82 (1.2%)		1/85 (1.2%)		1/84 (1.2%)		2/83 (2.4%)
Back Pain	1/82 (1.2%)		1/85 (1.2%)		3/84 (3.6%)		0/83 (0%)
Osteoarthritis	0/82 (0%)		1/85 (1.2%)		0/84 (0%)		2/83 (2.4%)
Pain in Extremity	0/82 (0%)		0/85 (0%)		1/84 (1.2%)		2/83 (2.4%)
Nervous system disorders
Dizziness	0/82 (0%)		0/85 (0%)		1/84 (1.2%)		2/83 (2.4%)
Headache	1/82 (1.2%)		2/85 (2.4%)		3/84 (3.6%)		5/83 (6%)
Tension Headache	0/82 (0%)		0/85 (0%)		0/84 (0%)		2/83 (2.4%)
Psychiatric disorders
Anxiety	0/82 (0%)		0/85 (0%)		2/84 (2.4%)		0/83 (0%)
Insomnia	3/82 (3.7%)		1/85 (1.2%)		0/84 (0%)		2/83 (2.4%)
Sleep Disorder	0/82 (0%)		0/85 (0%)		0/84 (0%)		2/83 (2.4%)
Respiratory, thoracic and mediastinal disorders
Cough	0/82 (0%)		2/85 (2.4%)		2/84 (2.4%)		0/83 (0%)
Sinus Congestion	1/82 (1.2%)		1/85 (1.2%)		1/84 (1.2%)		2/83 (2.4%)
Skin and subcutaneous tissue disorders
Rash	0/82 (0%)		1/85 (1.2%)		2/84 (2.4%)		0/83 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.