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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 : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

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 QD Drug: Lorcaserin 10 mg BID Drug: Matching Placebo Phase 3

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
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lorcaserin 10 mg QD
Lorcaserin 10 mg tablet each morning and placebo tablet each evening
Drug: Lorcaserin 10 mg 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 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.



Primary Outcome Measures :
  1. Co-primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 [ Time Frame: 52 weeks ]

    The proportion of patients with a reduction from baseline body weight of 5% or more after 52 weeks.

    Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1.



Secondary Outcome Measures :
  1. Percent Change in Body Weight From Baseline to Week 52 [ Time Frame: 52 weeks ]
    The % change in body weight (kg) from baseline to week 52.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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

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
United States, California
Arena Pharmaceuticals, Inc.
San Diego, California, United States, 92121
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
Study Director: William Shanahan, MD Arena Pharmaceuticals
Principal Investigator: Steven Smith, MD Pennington Biomedical Research Center

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

Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00603291     History of Changes
Other Study ID Numbers: APD356-010
First Posted: January 29, 2008    Key Record Dates
Results First Posted: February 7, 2013
Last Update Posted: February 7, 2013
Last Verified: January 2013

Keywords provided by Arena Pharmaceuticals:
obesity
weight loss
lorcaserin
APD356
BLOOM-DM
hypertension
dyslipidemia
sleep apnea
glucose tolerance
cardiovascular disease
Arena

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms