BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Obesity

Intervention / Treatment
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* Drug: Lorcaserin 10 mg once daily (QD)
* Drug: Lorcaserin 10 mg twice a day (BID)
* Drug: Matching Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lorcaserin 10 mg QD<br>Lorcaserin 10 mg tablet each morning and placebo tablet each evening | Drug: Lorcaserin 10 mg once daily (QD)<br>* Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.<br>* Other names: APD356;|
| Experimental: Lorcaserin 10 mg BID<br>Lorcaserin 10 mg tablet each morning and evening | Drug: Lorcaserin 10 mg twice a day (BID)<br>* Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.<br>* Other names: APD356;|
| Placebo Comparator: Matching Placebo<br>Matching placebo tablet each morning and evening | Drug: Matching Placebo<br>* Matching placebo tablet each morning and evening for a duration of 52 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks. | Baseline and Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Body Weight From Baseline to Week 52 | The percent change in body weight (kg) from baseline to week 52. | Baseline and Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, weight loss, lorcaserin, APD356, BLOOM-DM, hypertension, dyslipidemia, sleep apnea, glucose tolerance, cardiovascular disease, Arena