Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Arena Pharmaceuticals |
---|---|
Information provided by: | Arena Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00603291 |
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.
Condition | Intervention | Phase |
---|---|---|
Obesity |
Drug: lorcaserin Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 750 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
lorcaserin 10 mg QD
|
Drug: lorcaserin
lorcaserin 10 mg QD
|
2: Experimental
lorcaserin 10 mg BID
|
Drug: lorcaserin
lorcaserin 10 mg BID
|
3: Placebo Comparator
placebo
|
Drug: placebo
placebo
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Scott Stubbe | 858-453-7200 ext 1733 | sstubbe@arm.com |
Contact: Marianne Mancini | 858-453-7200 ext 1602 | mmancini@arenapharm.com |
United States, California | |
Arena Pharmaceuticals | Recruiting |
San Diego, California, United States, 92121 | |
Contact: Brian Raether 858-453-7200 ext 1732 braether@arenapharm.com | |
Contact: Scott Stubbe 858-453-7200 ext 1602 sstubbe@arenapharm.com |
Study Director: | Christen M Anderson, MD, PhD | Arena Pharmaceuticals |
Responsible Party: | Arena Pharmaceuticals ( c/o: Vice President and Chief Medical Officer ) |
Study ID Numbers: | APD356-010 |
Study First Received: | January 17, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00603291 |
Health Authority: | United States: Food and Drug Administration |
Obesity Weight loss lorcaserin APD356 BLOOM-DM Hypertension |
Dyslipidemia Sleep apnea glucose tolerance cardiovascular disease Arena |
Obesity Sleep Apnea Syndromes Metabolic Diseases Apnea Diabetes Mellitus Endocrine System Diseases Overweight Body Weight Signs and Symptoms |
Diabetes Mellitus, Type 2 Weight Loss Nutrition Disorders Overnutrition Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Dyslipidemias Hypertension |