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Clinical Trial Details

Trial ID: L6961
Source ID: NCT00156897
Associated Drug: Atl-962
Title: Efficacy and Safety of ATL-962 in Obese Diabetics
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Non-Insulin-Dependent Diabetes Mellitus|Obesity
Interventions: DRUG: ATL-962|DRUG: Orlistat
Outcome Measures: Primary: Absolute weight loss compared to baseline | Secondary: 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
Sponsor/Collaborators: Sponsor: Alizyme
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 600
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2004-12
Completion Date: 2005-10
Results First Posted:
Last Update Posted: 2006-08-29
Locations: Aalborg Sygehus Nord, Aalborg, Denmark|Aarhus University Hospital, Aarhus, DK-8000, Denmark|Bispebjerg Hospital, Copenhagen, DK-2400, Denmark|Gentofte Hospital, Hellerup, DK-2900, Denmark|Hvidovre Hospital, Hvidovre, DK-2650, Denmark|Odense University Hospital, Odense, Denmark|Lääkärikeskus Minerva, Eura, 27510, Finland|Obesity Research Unit, Helsinki, 00100, Finland|Suomen Terveystalo, Jyvaskyla, 40100, Finland|Oy Foodfiles Limited, Kuopio, Finland|Oulun Diakonissalaitos, Oulu, 90100, Finland|University of Oulu, Oulu, Finland|Turku University Hospital, Turku, 20520, Finland|Allevon, Den Bosch Ziekenhuis, Netherlands|Allevon, DN de Bilt, Netherlands|Zeikenhuisgroep Twente, Hengelo, Netherlands|Nederlandse Obesitas Klinik, Hilversum, Netherlands|Sint Franciscus Gasthuis, Rotterdam, Netherlands|Sahlgrenska University Hospital, Goteborg, Sweden|Linkoping University Hospital, Linkoping, Sweden|Karolinsaka University Hospital, Stockholm, Sweden|Norrlands Universitetssjukhus, Umea, Sweden|Samariterhemmets Sjukhus, Uppsala, Sweden|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|Clinical Research Centre, Crosby, Liverpool, United Kingdom|Liverpool University Hospital, Liverpool, United Kingdom|Queen Mary's School of Medicine & Dentistry, London, E1 2AA, United Kingdom|Hammersmith Hospital, London, United Kingdom|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
URL: https://clinicaltrials.gov/show/NCT00156897