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Completed

NCT Number: NCT00603291

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

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.

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Key information

Conditions

Obesity Apnea Body Weight Body Weight Changes Cardiovascular Diseases Dyslipidemias Dyssomnias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arena Pharmaceuticals, Inc.

San Diego, California, 92121, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lorcaserin 10 mg once daily (QD)

Drug

Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.

Other names: APD356

Lorcaserin 10 mg twice a day (BID)

Drug

Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.

Other names: APD356

Matching Placebo

Drug

Matching placebo tablet each morning and evening for a duration of 52 weeks.

Primary outcomes

  1. Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52

    Time frame: Baseline and Week 52

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

Secondary outcomes

  1. Percent Change in Body Weight From Baseline to Week 52

    Time frame: Baseline and Week 52

    The percent change in body weight (kg) from baseline to week 52.

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 29, 2008
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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