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ISRCTN
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ISRCTN62647464
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ClinicalTrials.gov identifier
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Public title
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Phase II, multicentre, double blind, placebo controlled, parallel group, dose ranging study of ATL-962 (cetilistat) to assess weight loss, safety and tolerability in obese patients with Type II diabetes being treated with metformin, in comparison with orlistat
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Scientific title
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Acronym
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N/A
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Serial number at source
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ATL-962/175/CL, orlistat
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Study hypothesis
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Does ATL-962 induce weight loss in diabetic patients and is its safety and tolerability profile superior to that of orlistat in such patients?
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised three arm placebo controlled parallel group trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Obesity in patients with Type II diabetes
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Participants - inclusion criteria
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1. Type II diabetic patients
2. Aged 18-65
3. Body Mass Index (BMI) between 28 kg/m2 and 45 kg/m2
4. Glycosylated haemaglobin (HbA1c) value between 6% and 10%
5. Being treated with a stable dose of metformin
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Participants - exclusion criteria
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1. Significant weight loss in the previous 3 months
2. Weight gain during the run-in period
3. Other serious systemic disease, except for controlled hypertension, mild asthma, and primary hypothyroidism
4. History of GI disorders
5. Previous surgery for weight loss
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Anticipated start date
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01/12/2004
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Anticipated end date
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30/06/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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600 patients randomised
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Interventions
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ATL-962 (40 mg, 80 mg, or 120 mg), or placebo, or orlistat (120 mg) three times a day for 12 weeks
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Primary outcome measure(s)
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Absolute weight loss compared to baseline
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Secondary outcome measure(s)
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Proportion of patients achieving 5% or 10% weight loss; changes in waist circumference; changes in lipid profiles; changes in markers of diabetes; incidence of GI adverse events; changes in other safety parameters
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Sources of funding
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Alizyme (UK)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19461584
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Contact name
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Prof
Peter
Kopelman
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Address
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Barts and The London
Queen Mary's School of Medicine & Dentistry
30-32 Newark Street
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City/town
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London
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Zip/Postcode
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E1 2AA
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Country
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United Kingdom
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Sponsor
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Alizyme (UK)
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Address
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Granta Park
Great Abington
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City/town
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Cambridge
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Zip/Postcode
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CB1 6GX
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Country
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United Kingdom
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Tel
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+44 (0)1223 896 000
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Fax
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+44 (0)1223 896 001
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Email
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Medical.Information@alizyme.co.uk
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Sponsor website:
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http://www.alizyme.com
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Date applied
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05/09/2005
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Last edited
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14/10/2009
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Date ISRCTN assigned
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16/09/2005
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