Efficacy and Safety of ATL-962 in Obese Diabetics

Condition(s) targeted: Non-Insulin-Dependent Diabetes Mellitus; Obesity

Intervention: ATL-962 (Drug); Orlistat (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Alizyme

Official(s) and/or principal investigator(s):
Peter Kopelman, Principal Investigator, Affiliation: Queen Mary's School of Medicine & Dentistry, London, UK

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

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Absolute weight loss compared to baseline

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Hvidovre Hospital, Hvidovre DK-2650, Denmark

Aarhus University Hospital, Aarhus DK-8000, Denmark

Gentofte Hospital, Hellerup DK-2900, Denmark

Bispebjerg Hospital, Copenhagen DK-2400, Denmark

Aalborg Sygehus Nord, Aalborg, Denmark

Odense University Hospital, Odense, Denmark

Obesity Research Unit, Helsinki 00100, Finland

Oulun Diakonissalaitos, Oulu 90100, Finland

Turku University Hospital, Turku 20520, Finland

Suomen Terveystalo, Jyvaskyla 40100, Finland

Lääkärikeskus Minerva, Eura 27510, Finland

Oy Foodfiles Limited, Kuopio, Finland

University of Oulu, Oulu, Finland

Allevon, DN de Bilt, Netherlands

Allevon, Den Bosch Ziekenhuis, Netherlands

Nederlandse Obesitas Klinik, Hilversum, Netherlands

Sint Franciscus Gasthuis, Rotterdam, Netherlands

Zeikenhuisgroep Twente, Hengelo, Netherlands

Karolinsaka University Hospital, Stockholm, Sweden

Linkoping University Hospital, Linkoping, Sweden

Sahlgrenska University Hospital, Goteborg, Sweden

Samariterhemmets Sjukhus, Uppsala, Sweden

Norrlands Universitetssjukhus, Umea, Sweden

Queen Mary's School of Medicine & Dentistry, London E1 2AA, United Kingdom

Hammersmith Hospital, London, United Kingdom

Glasgow Royal Infirmary, Glasgow, United Kingdom

Luton & Dunstable Hospital, Luton, United Kingdom

Aberdeen Royal Infirmary, Aberdeen, United Kingdom

James Cook University Hospital, Middlesborough, 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

Clinical Research Centre, Wigan, United Kingdom

Starting date: December 2004
Ending date: October 2005
Last updated: August 25, 2006