BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Obesity Weight Loss, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | December 2007 |
| End Date: | October 2010 |
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)
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.
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.
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
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