Phase 3
Completed N=604
BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
Source: ClinicalTrials.gov NCT00603291 ↗Enrolled (actual)
604
Serious AEs
6.8%
Results posted
Feb 2013
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.