BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus - Full Text View

Sponsor:	Arena Pharmaceuticals
Information provided by:	Arena Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00603291

Purpose

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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)

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 High Blood Pressure Obesity Weight Control

Drug Information available for: APD-356

U.S. FDA Resources

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
Study Completion Date:	October 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 lorcaserin 10 mg QD	Drug: lorcaserin lorcaserin 10 mg QD Other Name: APD356
Experimental: 2 lorcaserin 10 mg BID	Drug: lorcaserin lorcaserin 10 mg BID Other Name: APD356
Placebo Comparator: 3 placebo	Drug: placebo placebo

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603291

Locations

United States, California
Arena Pharmaceuticals
San Diego, California, United States, 92121

Sponsors and Collaborators

Arena Pharmaceuticals

Investigators

Study Director:

Christen M Anderson, MD, PhD

Arena Pharmaceuticals

More Information

Additional Information:

Arena Pharmaceuticals, Inc. Home Page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	c/o: Vice President and Chief Medical Officer, Arena Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00603291 History of Changes
Other Study ID Numbers:	APD356-010
Study First Received:	January 17, 2008
Last Updated:	March 30, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Arena Pharmaceuticals:

Obesity
Weight loss
lorcaserin
APD356
BLOOM-DM
Hypertension

Dyslipidemia
Sleep apnea
glucose tolerance
cardiovascular disease
Arena

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012