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

Completed · Phase 3 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00603291

Run by

Eisai Inc.

People needed

604

Starts

2007-12-01

Expected to finish

2010-10-01

Last updated by the study team

2019-10-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arena Pharmaceuticals, Inc. — San Diego, California, United States

Full record on ClinicalTrials.gov

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