Clinical trial NCT00156897: Efficacy and Safety of ATL-962 in Obese Diabetics
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Insulin-Dependent Diabetes Mellitus
Obesity
Keywords: Non-insulin-dependent diabetes mellitus
NIDDM
Type II diabetes
Obesity
Lipase inhibitor
Lead sponsor: Alizyme
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Absolute weight loss compared to baseline
Secondary outcomes:
measure: Proportion of patients achieving 5% or 10% weight loss
measure: Changes in waist circumference
measure: Changes in lipid profiles
measure: Changes in markers of diabetes
measure: Incidence of gastrointestinal adverse effects
measure: Changes in other safety parameters
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Sygehus Nord
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Eura
country: Finland
facility: Lääkärikeskus Minerva
city: Helsinki
country: Finland
facility: Obesity Research Unit
city: Jyvaskyla
country: Finland
facility: Suomen Terveystalo
city: Kuopio
country: Finland
facility: Oy Foodfiles Limited
city: Oulu
country: Finland
facility: Oulun Diakonissalaitos
city: Oulu
country: Finland
facility: University of Oulu
city: Turku
country: Finland
facility: Turku University Hospital
city: Den Bosch Ziekenhuis
country: Netherlands
facility: Allevon
city: DN de Bilt
country: Netherlands
facility: Allevon
city: Hengelo
country: Netherlands
facility: Zeikenhuisgroep Twente
city: Hilversum
country: Netherlands
facility: Nederlandse Obesitas Klinik
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Gasthuis
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Linkoping
country: Sweden
facility: Linkoping University Hospital
city: Stockholm
country: Sweden
facility: Karolinsaka University Hospital
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus
city: Uppsala
country: Sweden
facility: Samariterhemmets Sjukhus
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Birmingham
country: United Kingdom
facility: Clinical Research Centre Edgbaston
city: Coventry
country: United Kingdom
facility: Walsgrave Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Liverpool
country: United Kingdom
facility: Clinical Research Centre, Crosby
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospital
city: London
country: United Kingdom
facility: Queen Mary's School of Medicine & Dentistry
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Luton
country: United Kingdom
facility: Luton & Dunstable Hospital
city: Manchester
country: United Kingdom
facility: Clinical Research Centre
city: Middlesborough
country: United Kingdom
facility: James Cook University Hospital
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
city: Wigan
country: United Kingdom
facility: Clinical Research Centre
Study officials:
affiliation: Queen Mary's School of Medicine & Dentistry, London, UK
name: Peter Kopelman
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.