Efficacy and Safety of ATL-962 in Obese Diabetics - Tabular View

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

August 25, 2006

Start Date ^ICMJE

December 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Absolute weight loss compared to baseline

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00156897 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of ATL-962 in Obese Diabetics

Official Title ^ICMJE

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

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Non-Insulin-Dependent Diabetes Mellitus
Obesity

Intervention ^ICMJE

Drug: ATL-962
Drug: Orlistat

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

600

Completion Date

October 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark, Finland, Netherlands, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00156897

Responsible Party

Study ID Numbers ^ICMJE

ATL-962/175/CL

Study Sponsor ^ICMJE

Alizyme

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Peter Kopelman

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

Information Provided By

Alizyme

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP