Phase 2
Completed N=335
Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
Source: ClinicalTrials.gov NCT02243202 ↗Enrolled (actual)
335
Serious AEs
0.3%
Results posted
Oct 2016
Primary outcomePrimary: Percent Change From Baseline in Body Weight at Week 26 — -0.6; -4.1; -1.9; -7.5 Percent Change — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Body Weight at Week 26 |
-0.6; -4.1; -1.9; -7.5 | <0.001 sig |
| SECONDARY Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26 |
17.5; 41.7; 17.9; 66.7 | 0.002 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 26 |
-2.7; -1.4; -3.1; -6.9 | 0.456 |
| SECONDARY Absolute Change From Baseline in Body Weight at Week 26 |
-0.6; -4.1; -1.9; -7.3 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Must have BMI >=30 kg/m2 and =27 kg/m2 and =) 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
Data sourced from ClinicalTrials.gov (NCT02243202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.