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)

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.

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