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| Sponsored by: |
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: | 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 |
| Estimated Enrollment: | 600 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | October 2005 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Peter Kopelman | Queen Mary's School of Medicine & Dentistry, London, UK |
More Information
| Study ID Numbers: | ATL-962/175/CL |
| Study First Received: | September 8, 2005 |
| Last Updated: | August 25, 2006 |
| ClinicalTrials.gov Identifier: | NCT00156897 History of Changes |
| Health Authority: | United Kingdom: Department of Health |
|
Non-insulin-dependent diabetes mellitus NIDDM Type II diabetes Obesity Lipase inhibitor |
|
Obesity Metabolic Diseases Metformin Diabetes Mellitus Endocrine System Diseases Overweight Body Weight Anti-Obesity Agents Signs and Symptoms |
Orlistat Diabetes Mellitus, Type 2 Weight Loss Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
|
Obesity Metabolic Diseases Molecular Mechanisms of Pharmacological Action Diabetes Mellitus Endocrine System Diseases Overweight Enzyme Inhibitors Pharmacologic Actions Body Weight |
Anti-Obesity Agents Signs and Symptoms Orlistat Therapeutic Uses Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Glucose Metabolism Disorders Central Nervous System Agents |
