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Trial record 1 of 1 for:    BLOOM-DM
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BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00603291
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : February 7, 2013
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Lorcaserin 10 mg once daily (QD) Drug: Lorcaserin 10 mg twice a day (BID) Drug: Matching Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 604 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : December 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Lorcaserin

Arms and Interventions
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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 Name: 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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603291


Locations
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United States, California
Arena Pharmaceuticals, Inc.
San Diego, California, United States, 92121
Sponsors and Collaborators
Eisai Inc.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00603291    
Other Study ID Numbers: APD356-010
First Posted: January 29, 2008    Key Record Dates
Results First Posted: February 7, 2013
Last Update Posted: October 2, 2019
Last Verified: August 2019
Keywords provided by Eisai Inc.:
BLOOM-DM
obesity
weight loss
lorcaserin
APD356
hypertension
 dyslipidemia
sleep apnea
glucose tolerance
cardiovascular disease
Arena
Additional relevant MeSH terms:
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Obesity
Diabetes Mellitus
Overweight
Overnutrition
Nutrition Disorders
 Body Weight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases