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

Further Study Details: 

Primary Outcomes: Absolute weight loss compared to baseline
Secondary Outcomes: 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
Expected Total Enrollment:  600

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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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 hypertention, mild asthma, and primary hypothyroidism
• History of GI disorders
• Previous surgery for weight loss

Denmark
      Hvidovre Hospital, Hvidovre,  DK-2650,  Denmark
      Aarhus University Hospital, Aarhus,  DK-8000,  Denmark
      Gentofte Hospital, Hellerup,  DK-2900,  Denmark
      Bispebjerg Hospital, Copenhagen,  DK-2400,  Denmark
      Aalborg Sygehus Nord, Aalborg,  Denmark
      Odense University Hospital, Odense,  Denmark
Finland
      Obesity Research Unit, Helsinki,  00100,  Finland
      Oulun Diakonissalaitos, Oulu,  90100,  Finland
      Turku University Hospital, Turku,  20520,  Finland
      Suomen Terveystalo, Jyvaskyla,  40100,  Finland
      Lääkärikeskus Minerva, Eura,  27510,  Finland
      Oy Foodfiles Limited, Kuopio,  Finland
      University of Oulu, Oulu,  Finland
Netherlands
      Allevon, DN de Bilt,  Netherlands
      Allevon, Den Bosch Ziekenhuis,  Netherlands
      Nederlandse Obesitas Klinik, Hilversum,  Netherlands
      Sint Franciscus Gasthuis, Rotterdam,  Netherlands
      Zeikenhuisgroep Twente, Hengelo,  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,  E1 2AA,  United Kingdom
      Hammersmith Hospital, London,  United Kingdom
      Glasgow Royal Infirmary, Glasgow,  United Kingdom
      Luton & Dunstable Hospital, Luton,  United Kingdom
      Aberdeen Royal Infirmary, Aberdeen,  United Kingdom
      James Cook University Hospital, Middlesborough,  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
      Clinical Research Centre, Wigan,  United Kingdom

Study chairs or principal investigators

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

Study ID Numbers:  ATL-962/175/CL
Last Updated:  September 10, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00156897
Health Authority: United Kingdom: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13