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
|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|
|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 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.
- 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.
- 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.
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|
|Study Director:||William Shanahan, MD||Arena Pharmaceuticals|
|Principal Investigator:||Steven Smith, MD||Pennington Biomedical Research Center|