BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
NCT ID: NCT00603291
Last Updated: 2019-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
604 participants
INTERVENTIONAL
2007-12-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lorcaserin 10 mg QD
Lorcaserin 10 mg tablet each morning and placebo tablet each evening
Lorcaserin 10 mg once daily (QD)
Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening
Lorcaserin 10 mg twice a day (BID)
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
Matching Placebo
Matching placebo tablet each morning and evening
Matching Placebo
Matching placebo tablet each morning and evening for a duration of 52 weeks.
Interventions
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Lorcaserin 10 mg once daily (QD)
Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
Lorcaserin 10 mg twice a day (BID)
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
Matching Placebo
Matching placebo tablet each morning and evening for a duration of 52 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) 27 to 45 kg/m2, inclusive.
* Ability to complete a 1 year study
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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Arena Pharmaceuticals, Inc.
San Diego, California, United States
Countries
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References
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Magkos F, Nikonova E, Fain R, Zhou S, Ma T, Shanahan W. Effect of lorcaserin on glycemic parameters in patients with type 2 diabetes mellitus. Obesity (Silver Spring). 2017 May;25(5):842-849. doi: 10.1002/oby.21798. Epub 2017 Mar 27.
Weissman NJ, Smith SR, Fain R, Hall N, Shanahan WR. Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials. Obesity (Silver Spring). 2017 Jan;25(1):39-44. doi: 10.1002/oby.21695. Epub 2016 Nov 26.
Handelsman Y, Fain R, Wang Z, Li X, Fujioka K, Shanahan W. Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with >/=5% weight loss. Postgrad Med. 2016 Nov;128(8):740-746. doi: 10.1080/00325481.2016.1240591. Epub 2016 Oct 19.
Pi-Sunyer X, Shanahan W, Fain R, Ma T, Garvey WT. Impact of lorcaserin on glycemic control in overweight and obese patients with type 2 diabetes: analysis of week 52 responders and nonresponders. Postgrad Med. 2016 Aug;128(6):591-7. doi: 10.1080/00325481.2016.1208618. Epub 2016 Jul 18.
Nguyen CT, Zhou S, Shanahan W, Fain R. Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis. Clin Ther. 2016 Jun;38(6):1498-1509. doi: 10.1016/j.clinthera.2016.04.004. Epub 2016 May 17.
Weissman NJ, Sanchez M, Koch GG, Smith SR, Shanahan WR, Anderson CM. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials. Circ Cardiovasc Imaging. 2013 Jul;6(4):560-7. doi: 10.1161/CIRCIMAGING.112.000128. Epub 2013 May 9.
O'Neil PM, Smith SR, Weissman NJ, Fidler MC, Sanchez M, Zhang J, Raether B, Anderson CM, Shanahan WR. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Obesity (Silver Spring). 2012 Jul;20(7):1426-36. doi: 10.1038/oby.2012.66. Epub 2012 Mar 16.
Related Links
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Arena Pharmaceuticals, Inc. Home Page
Other Identifiers
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APD356-010
Identifier Type: -
Identifier Source: org_study_id
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