oom-DM Data May Save The Day With the FDA

This message got repeatedly rejected on the Yahoo board...but the title stuck!

I agree that the Bloom-DM sample size may not be enough to sway the vote on Lorcaserin as an obesity drug, but by adding significant improvement in combating Type II diabetes, the FDA may be swayed to approve.

My guess is that it will show an improved reduction in glucose levels in the blood stream. While weight reduction is important to the obesity issue, they have have specifically included people who have type II diabetes and would give the FDA a more compelling case to approve besides weight reduction.
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From the Clinical trials web site:

http://clinicaltrials.gov/ct2/show/NCT00603291?term=b loom&rank=6

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)


Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:

* Proportion (%) of patients achieving > or = 5% weight reduction at Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

* Change in body weight (kg) from Baseline to Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
* Change in glycemic control (i.e., HbA1c, fasting glucose, and use of medications for diabetes) from Baseline to Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
* Change in waist and hip measurements from Baseline to Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
* Change in total fat and lean body mass between Baseline and Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
* Change in blood pressure (systolic and diastolic) from Baseline to Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
* Change in lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) from Baseline to Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
* Change in Quality of Life measures from Baseline to Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]


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)

Eligibility

Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
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