Abstract | OBJECTIVE: RESEARCH DESIGN AND METHODS: This 26-week, phase 2a, randomized, double-blind, PBO-controlled, multicenter, parallel-group study enrolled individuals who were obese or overweight without type 2 diabetes (N = 335, aged 18-65 years, BMI ≥30 to <50 kg/m2 or BMI ≥27 to <50 kg/m2 with hypertension and/or dyslipidemia). Participants were randomized (1:1:1:1) to receive PBO, CANA 300 mg, PHEN 15 mg, or coadministration of CANA 300 mg and PHEN 15 mg (CANA/PHEN) orally once daily. The primary end point was percent change in body weight from baseline to week 26; key secondary end points were the proportion of participants achieving weight loss ≥5% and change from baseline in systolic blood pressure. RESULTS: CANA/PHEN provided statistically superior weight loss from baseline versus PBO at week 26 (least squares mean difference -6.9% [95% CI -8.6 to -5.2]; P < 0.001). CANA/PHEN also provided statistically superior achievement of weight loss ≥5% and reduction in systolic blood pressure compared with PBO. CANA/PHEN was generally well tolerated, with a safety and tolerability profile consistent with that of the individual components. CONCLUSIONS: CANA/PHEN produced meaningful reductions in body weight and was generally well tolerated in individuals who were overweight or obese without type 2 diabetes. Further studies are warranted to evaluate potential use of this combination for long-term weight management.
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Authors | Priscilla Hollander, Harold E Bays, Julio Rosenstock, Mary Ellen Frustaci, Albert Fung, Frank Vercruysse, Ngozi Erondu |
Journal | Diabetes care
(Diabetes Care)
Vol. 40
Issue 5
Pg. 632-639
(05 2017)
ISSN: 1935-5548 [Electronic] United States |
PMID | 28289041
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | © 2017 by the American Diabetes Association. |
Chemical References |
- Appetite Depressants
- Hypoglycemic Agents
- Thiophenes
- Canagliflozin
- Phentermine
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Topics |
- Adult
- Appetite Depressants
(administration & dosage, adverse effects)
- Blood Pressure
(drug effects)
- Canagliflozin
(administration & dosage, adverse effects)
- Diabetes Mellitus, Type 2
- Double-Blind Method
- Female
- Humans
- Hypoglycemic Agents
(administration & dosage, adverse effects)
- Male
- Middle Aged
- Obesity
(complications, drug therapy, physiopathology)
- Overweight
(complications, drug therapy, physiopathology)
- Phentermine
(administration & dosage, adverse effects)
- Thiophenes
(therapeutic use)
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