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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arena Pharmaceuticals; Eisai Inc.

Criteria

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