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

September 19, 2019 updated by: Eisai Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

604

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Arena Pharmaceuticals, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lorcaserin 10 mg QD
Lorcaserin 10 mg tablet each morning and placebo tablet each evening
Drug: Lorcaserin 10 mg once daily (QD)
Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
Other Names:
  • APD356
Experimental: Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening
Drug: Lorcaserin 10 mg twice a day (BID)
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
Other Names:
  • APD356
Placebo Comparator: Matching Placebo
Matching placebo tablet each morning and evening
Drug: Matching Placebo
Matching placebo tablet each morning and evening for a duration of 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52
Time Frame: Baseline and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Body Weight From Baseline to Week 52
Time Frame: Baseline and Week 52
The percent change in body weight (kg) from baseline to week 52.
Baseline and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 17, 2008

First Posted (Estimate)

January 29, 2008

Study Record Updates

Last Update Posted (Actual)

October 2, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APD356-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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