Status:
COMPLETED
Efficacy and Safety of ATL-962 in Obese Diabetics
Lead Sponsor:
Alizyme
Conditions:
Non-Insulin-Dependent Diabetes Mellitus
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Type II diabetes
- Body mass index 28-45kg/m2
- HbA1c 6%-10%
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00156897
Start Date
December 1 2004
End Date
October 1 2005
Last Update
August 29 2006
Active Locations (37)
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1
Aalborg Sygehus Nord
Aalborg, Denmark
2
Aarhus University Hospital
Aarhus, Denmark, DK-8000
3
Bispebjerg Hospital
Copenhagen, Denmark, DK-2400
4
Gentofte Hospital
Hellerup, Denmark, DK-2900