NCT00603291

BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus

A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients With Type 2 Diabetes Mellitus Managed With Oral Hypoglycemic Agent(s)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 604 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Lorcaserin 10 mg once daily (QD)	Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
DRUG	Lorcaserin 10 mg twice a day (BID)	Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
DRUG	Matching Placebo	Matching placebo tablet each morning and evening for a duration of 52 weeks.

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-06-01
• Completion: 2010-10-01
• First posted: 2008-01-29
• Last updated: 2019-10-02
• Results posted: 2013-02-07

Locations

1 site across 1 country: United States