Status:
COMPLETED
Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic con...
Eligibility Criteria
Inclusion
- Main
- Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening.
- HbA1c between 7.1% and 11.0%, inclusive.
- Insulin therapy should be the next appropriate step of diabetes treatment.
- Body Mass Index (BMI) \>25 kg/m2 and \<40 kg/m2.
- Main
Exclusion
- Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs.
- Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00099619
Start Date
September 1 2004
End Date
August 1 2005
Last Update
February 23 2015
Active Locations (26)
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1
Research Site
Westmead, New South Wales, Australia
2
Research Site
Daw Park, South Australia, Australia
3
Research Site
Fullarton, South Australia, Australia
4
Research Site
Box Hill, Victoria, Australia