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

Obesity Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603291
• Other study ID #: APD356-010
• Status: Completed
• Phase: Phase 3
• Start date: December 2007
• Est. completion date: October 2010

Study information

• Verified date: August 2019
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity
• Overweight

Intervention

Drug:
• Lorcaserin 10 mg once daily (QD)
Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
• Lorcaserin 10 mg twice a day (BID)
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
• Matching Placebo
Matching placebo tablet each morning and evening for a duration of 52 weeks.

Locations

Country	Name	City	State
United States	Arena Pharmaceuticals, Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52	The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.	Baseline and Week 52
Secondary	Percent Change in Body Weight From Baseline to Week 52	The percent change in body weight (kg) from baseline to week 52.	Baseline and Week 52

External Links

•   Arena Pharmaceuticals, Inc. Home Page