Status:
COMPLETED
A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as mea...
Eligibility Criteria
Inclusion
- Diagnosed with type 2 diabetes
- Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.
- HbA1c between 7.5% and 10.0%.
- BMI \>27.
Exclusion
- Receive 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 study.
- Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
- Treatment with the following medications: \*Insulin as outpatient therapy within last 3 months; \*Meglitinides, or acarbose within the last 3 months; \*Regular use of any drugs that directly affect gastrointestinal motility; \*Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; \*Anti-obesity agent use within the last 3 months.
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT00360334
Start Date
June 1 2006
End Date
April 1 2008
Last Update
April 7 2015
Active Locations (31)
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1
Research Site
Aberdeen, United Kingdom
2
Research Site
Bath, United Kingdom
3
Research Site
Blackburn, United Kingdom
4
Research Site
Bolton, United Kingdom