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Efficacy and Safety of ATL-962 in Obese Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00156897
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 29, 2006
Sponsor:
Information provided by:
Alizyme

Study Description
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Brief Summary:
The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic patients and whether its safety and tolerability profile is superior to that of orlistat in such patients

Condition or disease Intervention/treatment Phase
Non-Insulin-Dependent Diabetes Mellitus Obesity Drug: ATL-962 Drug: Orlistat Phase 2

Detailed Description:

Obesity is a significant and increasing clinical problem. There is a need for effective therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction.

In this study patients with Type II diabetes who are clinically obese will receive ATL-962 at one of three dose levels, or placebo, or orlistat (another lipase inhibitor). The study will investigate the amount of weight lost after 12 weeks' treatment and will compare the safety and tolerability profile of ATL-962 and orlistat.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multicentre Double Blind Placebo Controlled Parallel Group Dose Ranging Study of ATL-962 to Assess Weight Loss, Safety and Tolerability in Obese Patients With Type II Diabetes Being Treated With Metformin, in Comparison With Orlistat
Study Start Date : December 2004
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control
Drug Information available for: Orlistat

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Absolute weight loss compared to baseline

Secondary Outcome Measures :
  1. Proportion of patients achieving 5% or 10% weight loss
  2. Changes in waist circumference
  3. Changes in lipid profiles
  4. Changes in markers of diabetes
  5. Incidence of gastrointestinal adverse effects
  6. Changes in other safety parameters

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type II diabetes
  • Body mass index 28-45kg/m2
  • HbA1c 6%-10%

Exclusion Criteria:

  • Significant weight loss in the previous 3 months
  • Weight gain during the run-in period
  • Other serious systemic conditions, except controlled hypertension, mild asthma, and primary hypothyroidism
  • History of GI disorders
  • Previous surgery for weight loss
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156897


Locations
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Sponsors and Collaborators
Alizyme
Investigators
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Principal Investigator: Peter Kopelman Queen Mary's School of Medicine & Dentistry, London, UK
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00156897    
Other Study ID Numbers: ATL-962/175/CL
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 29, 2006
Last Verified: August 2006
Keywords provided by Alizyme:
Non-insulin-dependent diabetes mellitus
NIDDM
Type II diabetes
Obesity
Lipase inhibitor
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents