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
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|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||604 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
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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|
- 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
- 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
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
|United States, California|
|Arena Pharmaceuticals, Inc.|
|San Diego, California, United States, 92121|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Eisai Inc.|
|Other Study ID Numbers:||
|First Posted:||January 29, 2008 Key Record Dates|
|Results First Posted:||February 7, 2013|
|Last Update Posted:||October 2, 2019|
|Last Verified:||August 2019|
Glucose Metabolism Disorders
Endocrine System Diseases