Status:
COMPLETED
Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenati...
Eligibility Criteria
Inclusion
- Diagnosed with type 2 diabetes.
- Have been treated with one of the following treatment regimens for at least three months prior to screening: \*metformin alone; \*sulfonylurea (SU) alone; \*thiazolidinedione (TZD) alone; \*a combination of metformin and SU; \*a combination of metformin and TZD.
- HbA1c between 7.1% and 10.0%, inclusive.
- Body Mass Index (BMI) \> 25 kg/m\^2 and \< 45 kg/m\^2
Exclusion
- Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.
- Have characteristics contraindicating metformin, SU, or TZD use.
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
- Have used any prescription drug to promote weight loss within 3 months prior to screening.
- Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: \*insulin within 3 months prior to screening; \*alpha-glucosidase inhibitors within 3 months prior to screening; \*meglitinides within 3 months prior to screening; \*drugs that directly affect gastrointestinal motility
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
377 Patients enrolled
Trial Details
Trial ID
NCT00359879
Start Date
September 1 2006
End Date
July 1 2007
Last Update
February 23 2015
Active Locations (15)
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1
Research Site
Campinas, Brazil
2
Research Site
Curitiba, Brazil
3
Research Site
Fortaleza, Brazil
4
Research Site
Goiânia, Brazil