Efficacy and Safety of ATL-962 in Obese Diabetics

NCT ID: NCT00156897

Last Updated: 2006-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2005-10-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Non-Insulin-Dependent Diabetes Mellitus Obesity

Keywords

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Non-insulin-dependent diabetes mellitus NIDDM Type II diabetes Obesity Lipase inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ATL-962

Intervention Type DRUG

Orlistat

Intervention Type DRUG

Eligibility Criteria

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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 hypertension, mild asthma, and primary hypothyroidism
* History of GI disorders
* Previous surgery for weight loss
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alizyme

INDUSTRY

Sponsor Role lead

Principal Investigators

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Peter Kopelman

Role: PRINCIPAL_INVESTIGATOR

Queen Mary's School of Medicine & Dentistry, London, UK

Locations

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Aalborg Sygehus Nord

Aalborg, , Denmark

Site Status

Aarhus University Hospital

Aarhus, , Denmark

Site Status

Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Gentofte Hospital

Hellerup, , Denmark

Site Status

Hvidovre Hospital

Hvidovre, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Lääkärikeskus Minerva

Eura, , Finland

Site Status

Obesity Research Unit

Helsinki, , Finland

Site Status

Suomen Terveystalo

Jyväskylä, , Finland

Site Status

Oy Foodfiles Limited

Kuopio, , Finland

Site Status

Oulun Diakonissalaitos

Oulu, , Finland

Site Status

University of Oulu

Oulu, , Finland

Site Status

Turku University Hospital

Turku, , Finland

Site Status

Allevon

Den Bosch Ziekenhuis, , Netherlands

Site Status

Allevon

DN de Bilt, , Netherlands

Site Status

Zeikenhuisgroep Twente

Hengelo, , Netherlands

Site Status

Nederlandse Obesitas Klinik

Hilversum, , Netherlands

Site Status

Sint Franciscus Gasthuis

Rotterdam, , Netherlands

Site Status

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Linkoping University Hospital

Linköping, , Sweden

Site Status

Karolinsaka University Hospital

Stockholm, , Sweden

Site Status

Norrlands Universitetssjukhus

Umeå, , Sweden

Site Status

Samariterhemmets Sjukhus

Uppsala, , Sweden

Site Status

Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

Site Status

Royal United Hospital

Bath, , United Kingdom

Site Status

Clinical Research Centre Edgbaston

Birmingham, , United Kingdom

Site Status

Walsgrave Hospital

Coventry, , United Kingdom

Site Status

Glasgow Royal Infirmary

Glasgow, , United Kingdom

Site Status

Clinical Research Centre, Crosby

Liverpool, , United Kingdom

Site Status

Liverpool University Hospital

Liverpool, , United Kingdom

Site Status

Queen Mary's School of Medicine & Dentistry

London, , United Kingdom

Site Status

Hammersmith Hospital

London, , United Kingdom

Site Status

Luton & Dunstable Hospital

Luton, , United Kingdom

Site Status

Clinical Research Centre

Manchester, , United Kingdom

Site Status

James Cook University Hospital

Middlesbrough, , United Kingdom

Site Status

Royal Shrewsbury Hospital

Shrewsbury, , United Kingdom

Site Status

Clinical Research Centre

Wigan, , United Kingdom

Site Status

Countries

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Denmark Finland Netherlands Sweden United Kingdom

References

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Kopelman P, Groot Gde H, Rissanen A, Rossner S, Toubro S, Palmer R, Hallam R, Bryson A, Hickling RI. Weight loss, HbA1c reduction, and tolerability of cetilistat in a randomized, placebo-controlled phase 2 trial in obese diabetics: comparison with orlistat (Xenical). Obesity (Silver Spring). 2010 Jan;18(1):108-15. doi: 10.1038/oby.2009.155. Epub 2009 May 21.

Reference Type DERIVED
PMID: 19461584 (View on PubMed)

Other Identifiers

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ATL-962/175/CL

Identifier Type: -

Identifier Source: org_study_id