Efficacy and Safety of ATL-962 in Obese Diabetics

Phase 2

Completed

• Conditions: Non-Insulin-Dependent Diabetes Mellitus; Obesity

• Registration Number: NCT00156897
• Lead Sponsor: Alizyme

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

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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Study Completion: 2005-10
• Status Verified: 2006-08
• Last Update Submitted: 2006-08-25
• Last Update Posted: 2006-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Absolute weight loss compared to baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (35)

Obesity Research Unit; 🇫🇮 Helsinki, Finland

Oy Foodfiles Limited; 🇫🇮 Kuopio, Finland

Oulun Diakonissalaitos; 🇫🇮 Oulu, Finland

University of Oulu; 🇫🇮 Oulu, Finland

Allevon; 🇳🇱 DN de Bilt, Netherlands

Nederlandse Obesitas Klinik; 🇳🇱 Hilversum, Netherlands

Sint Franciscus Gasthuis; 🇳🇱 Rotterdam, Netherlands

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, United Kingdom

Aalborg Sygehus Nord; 🇩🇰 Aalborg, Denmark

Royal United Hospital; 🇬🇧 Bath, United Kingdom

Clinical Research Centre Edgbaston; 🇬🇧 Birmingham, United Kingdom

Glasgow Royal Infirmary; 🇬🇧 Glasgow, United Kingdom

Queen Mary's School of Medicine & Dentistry; 🇬🇧 London, United Kingdom

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Walsgrave Hospital; 🇬🇧 Coventry, United Kingdom

Liverpool University Hospital; 🇬🇧 Liverpool, United Kingdom

Sahlgrenska University Hospital; 🇸🇪 Goteborg, Sweden

Linkoping University Hospital; 🇸🇪 Linkoping, Sweden

Luton & Dunstable Hospital; 🇬🇧 Luton, United Kingdom

James Cook University Hospital; 🇬🇧 Middlesborough, United Kingdom

Royal Shrewsbury Hospital; 🇬🇧 Shrewsbury, United Kingdom

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Clinical Research Centre, Crosby; 🇬🇧 Liverpool, United Kingdom

Hammersmith Hospital; 🇬🇧 London, United Kingdom

Clinical Research Centre; 🇬🇧 Wigan, United Kingdom

Turku University Hospital; 🇫🇮 Turku, Finland

Lääkärikeskus Minerva; 🇫🇮 Eura, Finland

Odense University Hospital; 🇩🇰 Odense, Denmark

Gentofte Hospital; 🇩🇰 Hellerup, Denmark

Suomen Terveystalo; 🇫🇮 Jyvaskyla, Finland

Samariterhemmets Sjukhus; 🇸🇪 Uppsala, Sweden

Zeikenhuisgroep Twente; 🇳🇱 Hengelo, Netherlands

Karolinsaka University Hospital; 🇸🇪 Stockholm, Sweden

Norrlands Universitetssjukhus; 🇸🇪 Umea, Sweden