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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00603291 |
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Date of registration:
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17/01/2008 |
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Primary sponsor: |
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Public title:
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BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
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Scientific 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) |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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604 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00603291 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Christen M Anderson, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Arena Pharmaceuticals |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Drug: lorcaserin
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Drug: placebo
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Primary Outcome(s)
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Proportion (%) of patients achieving > or = 5% weight reduction at Week 52.
[Time Frame: Week 52]
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Secondary Outcome(s)
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Change in blood pressure (systolic and diastolic) from Baseline to Week 52.
[Time Frame: Week 52]
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Change in body weight (kg) from Baseline to Week 52.
[Time Frame: Week 52]
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Change in glycemic control (i.e., HbA1c, fasting glucose, and use of medications for diabetes) from Baseline to Week 52.
[Time Frame: Week 52]
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Change in lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) from Baseline to Week 52.
[Time Frame: Week 52]
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Change in Quality of Life measures from Baseline to Week 52.
[Time Frame: Week 52]
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Change in total fat and lean body mass between Baseline and Week 52.
[Time Frame: Week 52]
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Change in waist and hip measurements from Baseline to Week 52.
[Time Frame: Week 52]
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Secondary ID(s)
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APD356-010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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