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

Phase 3

Completed

• Conditions: Obesity
• Interventions: Drug: Lorcaserin 10 mg once daily (QD); Drug: Lorcaserin 10 mg twice a day (BID); Drug: Matching Placebo

• Registration Number: NCT00603291
• Lead Sponsor: Eisai Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-17
• Study First Submitted QC: 2008-01-17
• Study First Posted: 2008-01-29
• Primary Completion: 2010-06
• Study Completion: 2010-10
• Disposition First Submitted: 2012-07-26
• Disposition First Submitted QC: 2012-08-06
• Disposition First Posted: 2012-08-14
• Results First Submitted: 2013-01-04
• Results First Submitted QC: 2013-01-04
• Results First Posted: 2013-02-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 604

Inclusion Criteria

• Overweight/obese men and women with type 2 diabetes mellitus that is managed with oral anti-hyperglycemic agent(s).
• Body mass index (BMI) 27 to 45 kg/m2, inclusive.
• Ability to complete a 1 year study

Exclusion Criteria

• Pregnancy
• Use of insulin in any form, exenatide (Byetta) or pramlintide (Symlin) within 3 months prior to screening
• History of symptomatic heart valve disease
• Serious or unstable current or past medical conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lorcaserin 10 mg QD	Lorcaserin 10 mg once daily (QD)	Lorcaserin 10 mg tablet each morning and placebo tablet each evening
Lorcaserin 10 mg BID	Lorcaserin 10 mg twice a day (BID)	Lorcaserin 10 mg tablet each morning and evening
Matching Placebo	Matching Placebo	Matching placebo tablet each morning and evening

Primary Outcome Measures

Name	Time	Method
Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52	Baseline and Week 52	The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.

Secondary Outcome Measures

Name	Time	Method
Percent Change in Body Weight From Baseline to Week 52	Baseline and Week 52	The percent change in body weight (kg) from baseline to week 52.

Trial Locations

Locations (1)

Arena Pharmaceuticals, Inc.; 🇺🇸 San Diego, California, United States