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

Eisai

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Drug: Lorcaserin 10 mg twice a day (BID); Drug: Matching Placebo; Drug: Lorcaserin 10 mg once daily (QD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00603291

APD356-010

Details and patient eligibility

About

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.

Enrollment: 604 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

604 participants in 3 patient groups, including a placebo group

Lorcaserin 10 mg QD

Experimental group

Description:

Lorcaserin 10 mg tablet each morning and placebo tablet each evening

Treatment:

Drug: Lorcaserin 10 mg once daily (QD)

Lorcaserin 10 mg BID

Experimental group

Description:

Lorcaserin 10 mg tablet each morning and evening

Treatment:

Drug: Lorcaserin 10 mg twice a day (BID)

Matching Placebo

Placebo Comparator group

Description:

Matching placebo tablet each morning and evening

Treatment:

Drug: Matching Placebo