BLOOM-DM trial in patients with overweight/obesity and T2DM at Year 1*†1,4

Patients taking BELVIQ® demonstrated SIGNIFICANT REDUCTIONS IN HbA1c AND FASTING PLASMA GLUCOSE

All patients received lifestyle modification counseling1





  • The effect of BELVIQ® on cardiovascular morbidity and mortality has not been established
  • Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus who are being treated with antidiabetic medications, so measurement of blood sugar levels before and during treatment with BELVIQ is recommended. Decreases in doses of antidiabetic medications or changes in medication regimen should be considered
  • BELVIQ is not indicated for the treatment of type 2 diabetes

Results from a randomized, double-blind, clinical trial with obese or overweight adults with poorly controlled type 2 diabetes being treated with metformin and/or a sulfonylurea (SFU). Patients were randomized to BELVIQ 10 mg BID with lifestyle modification or to placebo with lifestyle modification. The primary endpoints were the proportion of patients with 5% weight loss from baseline, the proportion with 10% weight loss from baseline, and change in body weight from baseline to Week 52. Mean baseline weight BELVIQ 103.5 kg and placebo 102.3 kg.1

*Modified Intent-to-Treat population using Last Observation Carried Forward method; all patients who received study medication and had a postbaseline measurement. 34% of BELVIQ patients and 38% of placebo patients withdrew prior to Week 52.1

†At baseline, 91.5% of patients took metformin, 50.4% took an SFU, 41.9% took both.2

View Efficacy Data here

 

References Study Description Mean Changes in Cardiometabolic Parameters
  1. BELVIQ®/BELVIQ XR® [package insert]. Woodcliff Lake, NJ: Eisai Inc.
  2. Data on file.
  3. O’Neil PM. Smith SR, Weissman NJ, et al. Randomized placebo-controlled clinical trial of locaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Obesity. 2012;20(7):1426-1436.

Behavioral Modification and Lorcaserin for Overweight and Obesity Management-Diabetes Mellitus (BLOOM-DM)

  • Inclusion criteria1,2:
    • Adults aged 18 to 65 years1
    • BMI of 27 to 45 kg/m2
    • Type 2 diabetes being treated with metformin, an SFU, or both
    • Glycated hemoglobin (A1C) 7% to 10%
  • As part of a lifestyle modification program, all patients were instructed to exercise moderately for 30 minutes each day, and to reduce daily calorie intake to 600 kcal below estimated energy requirements2
  • Primary endpoints1:
    • Proportion of patients with 5% weight loss from baseline
    • Proportion with 10% weight loss from baseline
    • Change in body weight from baseline to Week 52
  • Selected secondary endpoints2:
    • Change from baseline in glycemic control measures, lipids, blood pressure, BMI, waist circumference
    • Proportion of patients who developed FDA-defined valvulopathy (mild or greater aortic regurgitation and/or moderate or greater mitral regurgitation) at Week 52

Mean Changes in Cardiometabolic Parameters and Waist Circumference at 1 Year1

  • The effect of BELVIQ® on cardiovascular morbidity and mortality has not been established.

*Modified Intent-to-Treat population using Last Observation Carried Forward method; all patients who received study medication and had a post-baseline measurement. 44% of BELVIQ patients and 51% of placebo patients withdrew prior to Week 52.

†Statistically significant versus placebo.

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