BLOOM-DM: Efficacy, Safety of Lorcaserin for Weight Loss Among Those with Type 2 Diabetes

O’Neil PM, Smith SR, Weissman NJ, et al. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Obesity. 2012;20:1426-1436. 

The Behavioral Modification and Lorcaserin for Obesity and Overweight Management in Diabetes Mellitus (BLOOM-DM) study was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of lorcaserin (administered in conjunction with a lifestyle modification program) for weight loss among those with type 2 diabetes.  

Subjects were aged 18-65 years and had A1C 7-10% at screening, BMI 27-45 kg/m2, type 2 diabetes treated with metformin, sulfonylurea, or both, and were able to participate in a moderate intensity exercise program.  

Participants were randomized over 1 year in a 1:1 ratio stratified by use of metformin or sulfonylurea* to the following groups:  

  • Lorcaserin 10 mg BID  
  • Lorcaserin 10 mg QD (lorcasesrin 10 mg in the AM; placebo in the PM)  
  • Placebo BID (before breakfast and dinner)  

All subjects received diet and exercise counseling at all study visits, which occurred at weeks 2 and 4 after randomization, and monthly thereafter. As part of the safety monitoring for this study, subjects received serial echocardiograms. Demographic characteristics were well-matched between groups.  

The study’s co-primary endpoints were: proportion of subjects achieving ≥5% reduction in baseline body weight at end of 1 year; change in weight; and proportion of subjects achieving ≥10% reduction in baseline body weight at end of 1 year. Secondary endpoints were changes in the following parameters from baseline: glycemic control (A1C), lipids, physical measures (eg, BMI, waist circumference), and quality of life.  

Results:
Primary endpoints (modified intention-to-treat analysis with last observation carried forward)
 

First co-primary endpoint: proportion of subjects achieving ≥5% reduction in baseline body weight  

  • Lorcaserin 10 mg BID (n=251): 37.5% (n=94); P<0.001 vs placebo  
  • Lorcaserin 10 mg QD† (n=94): 44.7% (n=42); P<0.001 vs placebo  
  • Placebo (n=248): 16.1% (n=40)  

Second co-primary endpoint: change in body weight  

  • Lorcaserin 10 mg BID (n=251): -10.4 lb change from baseline, -4.5% change (least-squares mean); P<0.001 vs placebo  
  • Lorcaserin 10 mg QD† (n=94): -11.0 lb change from baseline, -5.0% change (least-squares mean); P<0.001 vs placebo  
  • Placebo (n=248): -3.5 lb change from baseline, -1.5% change (least-squares mean)  

Third co-primary endpoint: proportion of subjects achieving ≥10% reduction in baseline body weight  

  • Lorcaserin 10 mg BID (n=251): 16.3% (n=41); P<0.001 vs placebo  
  • Lorcaserin 10 mg QD (n=94): 18.1% (n=17); P<0.001 vs placebo  
  • Placebo (n=248): 4.4% (n=11)  

With regard to secondary endpoints, when compared with the placebo group, use of lorcaserin resulted in significantly greater reductions in A1C and FPG and a significant decrease in heart rate. Changes in cholesterol and TG were small and not significant between groups. Systolic and diastolic blood pressure decreased from baseline in the lorcaserin BID and placebo groups; there were no significant differences between groups. Heart rate decreased significantly more in the lorcaserin BID and QD groups.  

The most common adverse events with greater incidence in lorcaserin group vs placebo were headache, back pain, nasopharyngitis, and nausea. An increased rate of symptomatic hypoglycemia was seen with lorcaserin vs placebo; no subjects reported severe hypoglycemia. At study end, echocardiographic valvulopathy that was not present at baseline was seen among 2.9% (6) in the lorcaserin 10 mg BID group; 2.5% (2) in the lorcaserin 10 mg QD group; and 0.5% (1) in the placebo group. The rate of serious adverse events was as follows: lorcaserin 10 mg BID: 6.3%; lorcaserin 10 mg QD: 8.4%; placebo: 6.7%.  

*Those taking both metformin and sulfonylurea were stratified with the sulfonylurea group 

Enrollment stopped after ~8 months due to slow study recruitment  

 

August 2012  

This overview was created by KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional/commercial interest. 

Related content: 

BLOOM-DM: Design  

BLOOM-DM: Primary and Secondary Endpoints  

BLOOM-DM: Subject Profile  

BLOOM-DM Co-Primary Endpoint: Proportion of Subjects Achieving ≥5% Reduction in Baseline Body Weight*  

BLOOM-DM Co-Primary Endpoint: Change in Body Weight*  

BLOOM-DM Co-Primary Endpoint: Proportion of Subjects Achieving ≥10% Reduction in Baseline Body Weight*  

BLOOM-DM: Secondary Endpoints  

BLOOM-DM: Adverse Events 

Last Modified: 3/23/2015