Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: exenatide (Drug); exenatide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
James Malone, MD, Study Director, Affiliation: Eli Lilly and Company
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) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with
type 2 diabetes.
Clinical Details
Official title: Safety and Efficacy of Exenatide Taken Before Lunch and Before Dinner Compared With Before Breakfast and Before Dinner in Patients With Type 2 Diabetes Using Oral Antidiabetic Therapy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12
Secondary outcome: Change in body weight from Baseline to Week 12, and if measured, at each visitChange in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Research Site, Campinas, Brazil
Research Site, Curitiba, Brazil
Research Site, Fortaleza, Brazil
Research Site, Goiania, Brazil
Research Site, Porto Alegre, Brazil
Research Site, Rio de Janeiro, Brazil
Research Site, Salvador, Brazil
Research Site, Sao Jose Do Rio Preto, Brazil
Research Site, Sao Paulo, Brazil
Research Site, Aguascalientes, Mexico
Research Site, Mexico City, Mexico
Research Site, San Luis Potosi, Mexico
Research Site, Guadalajara, Jalisco, Mexico
Research Site, Monterrey, Nuevo Leon, Mexico
Research Site, Merida, Yucatan, Mexico
Additional Information
Starting date: September 2006
Last updated: February 20, 2015
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