Frequently Asked Questions
- Why is the ELIXA study being conducted?
- Why should I participate?
- How often will I need to come for study visits?
- What treatment will be used in the ELIXA study?
- Can patients take any other medications while in the study?
- What procedures and tests will be done?
- Are there any risks involved?
- Are there any costs to participate?
- What if I decide to leave the study early?
- Will my health information be protected?
Why is the ELIXA study being conducted?
ELIXA is a clinical trial being done to see if lowering the blood sugar with an experimental anti-diabetes medication will prevent future heart attacks and strokes in people with type 2 diabetes who have already experienced a heart attack or unstable angina. The experimental medication, called lixisenatide, will be compared to a placebo (a substance that has no active drug).
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Why should I participate?
If you enroll in the ELIXA study you will receive all study-related medical care and diabetes testing supplies for free, as well as diet and exercise counseling. Most importantly, a study doctor will closely monitor your diabetes and heart disease.
You may experience benefits from your participation in this study, but there is not a guarantee. However, there is a possibility that the information gained from this study may, in the future, help others with your condition.
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How often will I need to come for study visits?
There will be both telephone visits and in-person visits to the study site for up to 47 months. In-person visits to the study site will take place every 12 weeks. After week 60, the in-person visits will occur every 16 weeks through week 156, and then every 20 weeks until the end of the study. When you join the study, you will be given a visit schedule.
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What treatments will be used in the ELIXA study?
This study will compare the investigational drug lixisenatide injected subcutaneously (just below the skin) once daily versus placebo (inactive substance) injection once daily to determine if there is an increase/decrease in the occurrence of future cardiovascular events such as heart attack and stroke.
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Can patients take any other medications while in the study?
Before taking any medication, including over-the-counter medications, you must discuss taking these medications with your study doctor. Some medications may interact with the study drug. This includes, but is not limited to, prescription medications and over-the-counter medications such as cough and cold remedies, pain relievers, antacids and any vitamins or herbal preparations. Use of these medications can also affect your medical test results and could cause you to be discontinued from the study. Your study doctor will let you know about the medications that you may or may not take while participating in this study. Use of illegal drugs during participation in this study is strictly forbidden and will result in you being discontinued from this study.
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What procedures and tests will be done?
As a participant in ELIXA, you will undergo a physical exam and a review of your medical history. During most visits, site staff will check your vital signs (blood pressure, temperature, and pulse), perform an electrocardiogram (ECG), and perform routine blood and urine tests, including a pregnancy test for women who are able to have children.
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Are there any risks involved?
As with any medication, the study drug has potential for risks, side effects, and discomforts.
Lixisenatide has generally been well tolerated in healthy subjects and subjects with diabetes. The most common side effects of lixisenatide include: headache, nausea, vomiting, diarrhea, dizziness, constipation and flatulence (gas). If any possible side effects and discomforts arise please immediately report them to your study doctor.
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Are there any costs to participate?
No, you will not be expected to pay for any costs associated with the ELIXA study. All study medication and study visits will be provided to you at no charge.
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What if I decide to leave the study early?
Participation in ELIXA will always remain strictly voluntary. You may end your participation at any time. Ending participation in the study will not alter the routine medical care that is received from your primary doctor.
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Will my health information be protected?
Yes, all information collected during ELIXA will be kept in strict confidence and in accordance with the official health privacy protection regulations (HIPAA). Your identity will remain anonymous and confidential.
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