Randomized Placebo-Controlled Clinical Trial of Lorcaserin for Weight Loss in Type 2 Diabetes Mellitus: The BLOOM-DM Study Article

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cited authors

  • O'Neil, Patrick M., Smith, Steven R., Weissman, Neil J., Fidler, Meredith C., Sanchez, Matilde, Zhang, Jinkun, Raether, Brian, Anderson, Christen M., Shanahan, William R.

funding text

  • The study was sponsored by Arena Pharmaceuticals, San Diego, CA. Clinical Trial Registration: http://www.ClinicalTrials.gov identifier number NCT00603291.

abstract

  • The BLOOM-DM (Behavioral Modification and Lorcaserin for Obesity and Overweight Management in Diabetes Mellitus) study evaluated efficacy and safety of lorcaserin for weight loss in patients with type 2 diabetes. Secondary objectives included evaluations of glycemic control, lipids, blood pressure, and quality of life. This 1-year, randomized, placebo-controlled trial enrolled 604 patients 1:1:1 to placebo, lorcaserin 10 mg once daily (QD) or lorcaserin 10 mg twice daily (BID). Patients were treated with metformin, a sulfonylurea (SFU) or both; had glycated hemoglobin (HbA(1c)) 7-10%; were 18-65 years old; and had BMI 27-45 kg/m(2). Patients received diet and exercise counseling. Safety monitoring included serial echocardiograms. Mean (+/- SD) age was 52.7 +/- 8.7; 54.2% were women; 60.5% were white, 20.9% were African American, and 13.8% were Hispanic. Mean (+/- SD) weight was 103.6 +/- 17.8 kg; BMI was 36.0 +/- 4.5 kg/m(2). Most patients (91.7%) took metformin; 50.2% took a SFU. More patients lost >= 5% body weight with lorcaserin BID (37.5%; P < 0.001) or lorcaserin QD (44.7%; P < 0.001) vs. placebo (16.1%; modified intent to treat (MITT)/last observation carried forward (LOCF)). Least square mean (+/- SEM) weight change was -4.5 +/- 0.35% with lorcaserin BID and -5.0 +/- 0.5% with lorcaserin QD vs. -1.5 +/- 0.36% with placebo (P < 0.001 for each). HbA(1c) decreased 0.9 +/- 0.06 with lorcaserin BID, 1.0 +/- 0.09 with lorcaserin QD, and 0.4 +/- 0.06 with placebo (P < 0.001 for each); fasting glucose decreased 27.4 +/- 2.5 mg/dl, -28.4 +/- 3.8 mg/dl, and 11.9 +/- 2.5 mg/dl, respectively (P < 0.001 for each). Symptomatic hypoglycemia occurred in 7.4% of patients on lorcaserin BID, 10.5% on lorcaserin QD, and 6.3% on placebo. Common adverse events were headache, back pain, nasopharyngitis, and nausea. Lorcaserin was associated with significant weight loss and improvement in glycemic control in patients with type 2 diabetes.

authors

Publication Date

  • July 1, 2012

webpage

published in

category

start page

  • 1426

end page

  • 1436

volume

  • 20

issue

  • 7

WoS Citations

  • 296

WoS References

  • 31