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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


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 visit

Change 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


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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