Status:
COMPLETED
A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
This study will examine the response of several doses of LY2148568 (exenatide) and assess the effect on glucose control and safety and tolerability in Japanese patients with type 2 diabetes.
Eligibility Criteria
Inclusion
- Diagnosed with type 2 diabetes.
- Have a body weight of \>=50 kg.
Exclusion
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Have participated in this study previously, or any other study using exenatide or other GLP-1 analogs.
- Are treated with any exogenous insulin within 3 months of screening.
- Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): \*drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine).
- Have characteristics contraindicating for concomitant medication, according to product-specific label.
- Have severe allergy or hypersensitivity to any drug.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00382239
Start Date
September 1 2006
End Date
May 1 2007
Last Update
February 23 2015
Active Locations (14)
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1
Research Site
Fukuoka, Japan
2
Research Site
Fukushima, Japan
3
Research Site
Gunma, Japan
4
Research Site
Hiroshima, Japan