Efficacy and Safety of ATL-962 in Obese Diabetics - Full Text View

Purpose

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	Intervention	Phase
Non-Insulin-Dependent Diabetes Mellitus Obesity	Drug: ATL-962 Drug: Orlistat	Phase II

MedlinePlus related topics:

Diabetes Obesity Weight Control

ChemIDplus related topics:

Metformin Metformin hydrochloride Orlistat Lipase Cetilistat

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Alizyme:

Primary Outcome Measures:

Absolute weight loss compared to baseline

Secondary Outcome Measures:

Proportion of patients achieving 5% or 10% weight loss
Changes in waist circumference
Changes in lipid profiles
Changes in markers of diabetes
Incidence of gastrointestinal adverse effects
Changes in other safety parameters

Estimated Enrollment:	600
Study Start Date:	December 2004
Estimated Study Completion Date:	October 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156897

Locations


Denmark
	Hvidovre Hospital
	Hvidovre, Denmark, DK-2650
	Aarhus University Hospital
	Aarhus, Denmark, DK-8000
	Gentofte Hospital
	Hellerup, Denmark, DK-2900
	Bispebjerg Hospital
	Copenhagen, Denmark, DK-2400
	Aalborg Sygehus Nord
	Aalborg, Denmark
	Odense University Hospital
	Odense, Denmark

Finland
	Obesity Research Unit
	Helsinki, Finland, 00100
	Oulun Diakonissalaitos
	Oulu, Finland, 90100
	Turku University Hospital
	Turku, Finland, 20520
	Suomen Terveystalo
	Jyvaskyla, Finland, 40100
	Lääkärikeskus Minerva
	Eura, Finland, 27510
	Oy Foodfiles Limited
	Kuopio, Finland
	University of Oulu
	Oulu, Finland

Netherlands
	Allevon
	DN de Bilt, Netherlands
	Zeikenhuisgroep Twente
	Hengelo, Netherlands
	Nederlandse Obesitas Klinik
	Hilversum, Netherlands
	Sint Franciscus Gasthuis
	Rotterdam, Netherlands
	Allevon
	Den Bosch Ziekenhuis, Netherlands

Sweden
	Karolinsaka University Hospital
	Stockholm, Sweden
	Linkoping University Hospital
	Linkoping, Sweden
	Sahlgrenska University Hospital
	Goteborg, Sweden
	Samariterhemmets Sjukhus
	Uppsala, Sweden
	Norrlands Universitetssjukhus
	Umea, Sweden

United Kingdom
	Queen Mary's School of Medicine & Dentistry
	London, United Kingdom, E1 2AA
	Hammersmith Hospital
	London, United Kingdom
	Glasgow Royal Infirmary
	Glasgow, United Kingdom
	Luton & Dunstable Hospital
	Luton, United Kingdom
	Aberdeen Royal Infirmary
	Aberdeen, United Kingdom
	Clinical Research Centre
	Wigan, United Kingdom
	Royal Shrewsbury Hospital
	Shrewsbury, United Kingdom
	Walsgrave Hospital
	Coventry, United Kingdom
	Royal United Hospital
	Bath, United Kingdom
	Liverpool University Hospital
	Liverpool, United Kingdom
	Clinical Research Centre Edgbaston
	Birmingham, United Kingdom
	Clinical Research Centre, Crosby
	Liverpool, United Kingdom
	Clinical Research Centre
	Manchester, United Kingdom
	James Cook University Hospital
	Middlesborough, United Kingdom

Sponsors and Collaborators

Alizyme

Investigators


Principal Investigator:	Peter Kopelman	Queen Mary's School of Medicine & Dentistry, London, UK

More Information

Study ID Numbers:	ATL-962/175/CL
First Received:	September 8, 2005
Last Updated:	August 25, 2006
ClinicalTrials.gov Identifier:	NCT00156897
Health Authority:	United Kingdom: Department of Health

Keywords provided by Alizyme:

Non-insulin-dependent diabetes mellitus

NIDDM

Type II diabetes

Obesity

Lipase inhibitor

Study placed in the following topic categories:

Obesity

Metabolic Diseases

Metformin

Diabetes Mellitus

Endocrine System Diseases

Overweight

Body Weight

Signs and Symptoms

Orlistat

Diabetes Mellitus, Type 2

Weight Loss

Nutrition Disorders

Overnutrition

Endocrinopathy

Glucose Metabolism Disorders

Metabolic disorder

Additional relevant MeSH terms:

Anti-Obesity Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Enzyme Inhibitors

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Alizyme
Information provided by:	Alizyme
ClinicalTrials.gov Identifier:	NCT00156897