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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

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

MedlinePlus related topics: Diabetes Diabetes Type 2 Obesity Weight Control

Drug Information available for: Orlistat Cetilistat

U.S. FDA Resources

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
Aalborg Sygehus Nord
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark, DK-8000
Bispebjerg Hospital
Copenhagen, Denmark, DK-2400
Gentofte Hospital
Hellerup, Denmark, DK-2900
Hvidovre Hospital
Hvidovre, Denmark, DK-2650
Odense University Hospital
Odense, Denmark
Finland
Lääkärikeskus Minerva
Eura, Finland, 27510
Obesity Research Unit
Helsinki, Finland, 00100
Suomen Terveystalo
Jyvaskyla, Finland, 40100
Oy Foodfiles Limited
Kuopio, Finland
Oulun Diakonissalaitos
Oulu, Finland, 90100
University of Oulu
Oulu, Finland
Turku University Hospital
Turku, Finland, 20520
Netherlands
Allevon
Den Bosch Ziekenhuis, Netherlands
Allevon
DN de Bilt, Netherlands
Zeikenhuisgroep Twente
Hengelo, Netherlands
Nederlandse Obesitas Klinik
Hilversum, Netherlands
Sint Franciscus Gasthuis
Rotterdam, Netherlands
Sweden
Sahlgrenska University Hospital
Goteborg, Sweden
Linkoping University Hospital
Linkoping, Sweden
Karolinsaka University Hospital
Stockholm, Sweden
Norrlands Universitetssjukhus
Umea, Sweden
Samariterhemmets Sjukhus
Uppsala, Sweden
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Royal United Hospital
Bath, United Kingdom
Clinical Research Centre Edgbaston
Birmingham, United Kingdom
Walsgrave Hospital
Coventry, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Liverpool University Hospital
Liverpool, United Kingdom
Clinical Research Centre, Crosby
Liverpool, United Kingdom
Hammersmith Hospital
London, United Kingdom
Queen Mary's School of Medicine & Dentistry
London, United Kingdom, E1 2AA
Luton & Dunstable Hospital
Luton, United Kingdom
Clinical Research Centre
Manchester, United Kingdom
James Cook University Hospital
Middlesborough, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, United Kingdom
Clinical Research Centre
Wigan, United Kingdom

Sponsors and Collaborators

Alizyme

Investigators

Principal Investigator:

Peter Kopelman

Queen Mary's School of Medicine & Dentistry, London, UK

More Information

No publications provided by Alizyme

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kopelman P, Groot Gde H, Rissanen A, Rossner S, Toubro S, Palmer R, Hallam R, Bryson A, Hickling RI. Weight loss, HbA1c reduction, and tolerability of cetilistat in a randomized, placebo-controlled phase 2 trial in obese diabetics: comparison with orlistat (Xenical). Obesity (Silver Spring). 2010 Jan;18(1):108-15. Epub 2009 May 21.

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

Keywords provided by Alizyme:

Non-insulin-dependent diabetes mellitus
NIDDM
Type II diabetes
Obesity
Lipase inhibitor

Additional relevant MeSH terms:

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

Body Weight
Signs and Symptoms
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012