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| Tracking Information | |||||
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| First Received Date ICMJE | September 8, 2005 | ||||
| Last Updated Date | August 25, 2006 | ||||
| Start Date ICMJE | December 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Absolute weight loss compared to baseline | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00156897 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety of ATL-962 in Obese Diabetics | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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 |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 600 | ||||
| Completion Date | October 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark, Finland, Netherlands, Sweden, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00156897 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | ATL-962/175/CL | ||||
| Study Sponsor ICMJE | Alizyme | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Alizyme | ||||
| Verification Date | August 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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