Phase 3
N=604
BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00603291 ↗Enrolled (actual)
604
Serious AEs
6.8%
Results posted
Feb 2013
Primary outcome: Primary: Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 — 37.5; 44.7; 16.1 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lorcaserin 10 mg once daily (QD) (Drug); Lorcaserin 10 mg twice a day (BID) (Drug); Matching Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 |
37.5; 44.7; 16.1 | <0.0001 sig |
| SECONDARY Percent Change in Body Weight From Baseline to Week 52 |
-4.54; -4.97; -1.48 | <0.0001 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00603291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.