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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00603291
First received: January 17, 2008
Last updated: January 4, 2013
Last verified: January 2013
  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 10 mg QD
Drug: Lorcaserin 10 mg BID
Drug: Matching Placebo
Phase 3

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:


Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:
  • Co-primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    The proportion of patients with a reduction from baseline body weight of 5% or more after 52 weeks.

    Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1.



Secondary Outcome Measures:
  • Percent Change in Body Weight From Baseline to Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The % change in body weight (kg) from baseline to week 52.


Enrollment: 604
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: Lorcaserin 10 mg QD
Lorcaserin 10 mg tablet each morning and placebo tablet each evening
Drug: Lorcaserin 10 mg QD
Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
Other Name: APD356
Experimental: Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening
Drug: Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
Other Name: APD356
Placebo Comparator: Matching Placebo
Matching placebo tablet each morning and evening
Drug: Matching Placebo
Matching placebo tablet each morning and evening for a duration of 52 weeks.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Arena Pharmaceuticals, Inc.
San Diego, California, United States, 92121
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
Study Director: William Shanahan, MD Arena Pharmaceuticals
Principal Investigator: Steven Smith, MD Pennington Biomedical Research Center
  More Information

Additional Information:
No publications provided by Arena Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00603291     History of Changes
Other Study ID Numbers: APD356-010
Study First Received: January 17, 2008
Results First Received: January 4, 2013
Last Updated: January 4, 2013
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 July 24, 2014