COR I 1-year randomized, double-blind, placebo-controlled trial (2010) | 1742 patients randomly categorized in a 1:1:1 ratio | i.16/360mg po ii.32/360mg po iii. placebo | i.-5.0% ii.-6.1% iii.-1.3% | i.39% ii.48% iii.16% | |
COR II 1-year randomized, double-blind, placebo-controlled trial (2013) | 1496 patients randomly categorized in a 2:1 ratio to NB 32/360mg or placebo; patients on NB with <5% weight loss in 28-44 week were reassigned to continue 32/360mg or increase daily dose to NB 48/360mg | i.32/360mg (or increased daily dose 48/360mg) ii.placebo | i.-6.4% ii.-1.2% | i.50.5% ii.17.1% | Random reassignment to higher dose did not change weight loss results |
COR-BMOD 1-year randomized, double-blind, placebo-controlled trial (2011) | 793 patients with obesity randomly categorized in a 1:3 ratio |
- i.
BMOD+ NB (32/350mg) - ii.
BMOD+ placebo
| i.-11.5% ii.-7.3% | i.66.4% ii.42.5% | The efficacy of NB is obvious, and a lifestyle change can increase weight loss |
COR-DIABETES 1-year randomized, double-blind, placebo-controlled trial (2013) | 505 patients overweight/obese and T2DM with/without oral anti-hypoglycemic agents randomly categorized in a 2:1 ratio | i.32/360mg ii. placebo | i.-5.0% ii.-1.8% | i.44.5% ii.18.9% | ↓HbA1c, certain improvements in CVD risk factors. ↑ nausea, constipation, vomiting |