Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes
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
1 other identifier
interventional
377
2 countries
15
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) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started Sep 2006
Shorter than P25 for phase_3 type-2-diabetes
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2006
CompletedFirst Posted
Study publicly available on registry
August 3, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFebruary 23, 2015
January 1, 2015
10 months
August 1, 2006
February 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12
Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12
Baseline, Week 12
Secondary Outcomes (3)
Change in body weight from Baseline to Week 12, and if measured, at each visit
Baseline, Weeks 4, 8, 12
Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit
Baseline, Weeks 4, 8, 12
Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12
Baseline, Weeks 4, 8, 12
Study Arms (2)
1 - exenatide before breakfast and dinner
EXPERIMENTAL2 - exenatide before lunch and dinner
ACTIVE COMPARATORInterventions
subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (15)
Research Site
Campinas, Brazil
Research Site
Curitiba, Brazil
Research Site
Fortaleza, Brazil
Research Site
Goiânia, Brazil
Research Site
Porto Alegre, Brazil
Research Site
Rio de Janeiro, Brazil
Research Site
Salvador, Brazil
Research Site
São José do Rio Preto, Brazil
Research Site
São Paulo, Brazil
Research Site
Aguascalientes, Aguascalientes, Mexico
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Monterrey, Nuevo León, Mexico
Research Site
San Luis Potosí City, San Luis Potosí, Mexico
Research Site
Mérida, Yucatán, Mexico
Research Site
Mexico City, Mexico
Related Publications (1)
Forti A, Garcia EG, Yu MB, Jimenez MC, Brodows RG, Oliveira JH. Efficacy and safety of exenatide administered before the two largest daily meals of Latin American patients with type 2 diabetes. Curr Med Res Opin. 2008 Sep;24(9):2437-47. doi: 10.1185/03007990802282398. Epub 2008 Jul 24.
PMID: 18662495DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Malone, MD
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2006
First Posted
August 3, 2006
Study Start
September 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
February 23, 2015
Record last verified: 2015-01