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Page 1 of 17Mercy IRB: GetGoal O Original Approval: 05/17/2013MMC# 2013-54 Amendment:

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Institutional Review BoardMercy Medical Center - DSM

Date: 5/17/2013

SPONSOR: Sanofi US.

TITLE:A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter, 24-week study assessing the safety and efficacy of lixisenatide in older patients with type 2

diabetes inadequately controlled on their current diabetes treatment regimen

PROTOCOL NUMBER: EFC12703

INVESTIGATOR: Anuj Bhargava, M.D.Iowa Diabetes and Endocrinology Research Center411 Laurel St. Suite 3262Des Moines, Iowa 50314

TELEPHONE: (515) 643-5122

AFTER HOURS

TELEPHONE: (515) 643-5100

This consent document may contain words that you do not understand. Please ask the studydoctor or the study staff to explain any words or information that you do not clearly understand.

INTRODUCTIONBefore agreeing to participate in this research study, it is important that you read andunderstand the following explanation of the proposed research study. This consent documentdescribes the purpose, procedures, benefits, risks, discomforts, and precautions of the study. Italso describes alternative procedures that are available to you and your right to withdraw fromthe study at any time. No guarantees or assurances can be made as to the results of the study.

If you are not completely truthful with your study doctor regarding your health history, you mayharm yourself by participating in this study.

The study is being conducted for Sanofi US. This institution is being paid by Sanofi US toconduct this study.

YOUR ROLE IN THE STUDYTaking part in a research study can be an inconvenience to your daily life. Please consider thetime commitments and responsibilities as a research study subject when you are deciding totake part.

NATURE AND PURPOSE OF THE STUDY

You are being asked to participate in a study of the investigational drug, lixisenatide(Lyxumia). An investigational drug is one that is not approved by the United States Food andDrug Administration (FDA).

The purpose of this study is to evaluate in older patients with Type 2 diabetes mellitus, thepossible risks and effectiveness of lixisenatide taken as self-injection once daily beforebreakfast over 24 weeks (6 months), when added to your current anti-diabetic medication (that


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could be sulfonylureas (SU), meglitinides, pioglitazone, metformin, or basal insulin. The effectsof lixisenatide are being compared to that of placebo (sterile solution without active substance)and the possible side effects of lixisenatide will also be investigated.

EXPECTED LENGTH OF THE STUDY AND NUMBER OF PARTICIPANTSThis study will include about 340 older subjects aged 70 years and above with type 2 diabetes,from about 75 research centers in the United States, Australia, Bulgaria, Canada, Denmark,Germany, Norway, Peru, Poland, Russia, South Africa, Spain, Sweden and UK.

This study will use competitive enrollment. This means that when a target number of subjectshave entered the treatment phase of the study, no additional subjects can enter the study.Therefore, it is possible that you could be in the screening phase, ready to enter the treatmentphase, and be discontinued without your consent if the targeted number of subjects has alreadyentered the treatment phase of the study.

Your participation in this study may last up to 31 weeks and include 23 study visits either at your

study doctors center or as telephone visits with the doctors office.

STUDY DRUGAbout Lixisenatide:In humans, a substance, called glucagon-like peptide 1 (GLP-1) is produced in the small boweland is released when eating. The pancreas is stimulated to produce more insulin, which lowersblood sugar. Patients with type 2 diabetes mellitus usually do not produce and release enoughinsulin when the blood sugar goes up, or the insulin does not work well enough. Subsequently,the blood sugar in type 2 diabetes patients goes higher than it should, which can cause damagein the blood vessels, on the eyes and kidneys.

Lixisenatide acts like natural GLP-1 and is more stable in a patients blood than the natural

GLP-1. Previous clinical research studies have shown that blood sugar in fasting state and afterbreakfast and lunch were lowered with lixisenatide. As it may happen with natural GLP-1,lixisenatide can also cause the stomach to take longer to empty after a meal. The effect mightbe reduced appetite and subsequently reduced body weight, but it might also lead to a feeling offullness, nausea and vomiting.

Lixisenatidehas generally been well tolerated by healthy and diabetic subjects. However, thereis always the possibility that you may experience some side effects.

The following side effects were found to occur at a slightly higher rate in patients treated withlixisenatide when compared to placebo (no active substance): nausea (feeling sick), vomiting,diarrhea, headache, feeling dizzy, somnolence, indigestion (dyspepsia), back pain, flu

(influenza), cold (upper respiratory tract infection), cystitis, and viral infection. Some events ofsweating and tremor appear to have been associated with the occurrence of low blood sugar(hypoglycemia). Hypoglycemia was mostly observed in patients receiving oral anti-diabeticmedications or insulin in addition to the Lixisenatide. Severe hypoglycemia, such ashypoglycemic unconsciousness, has also been observed infrequently in the studies in thesetting of insulin therapy or use of oral anti-diabetic medications of the sulfonylurea class beingused in addition (concomitant) to Lexisenatide.


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Nausea is most common when first starting lixisenatide, but decreases over time in mostpatients. Severe or prolonged nausea, vomiting or diarrhea might lead to dehydration and thenrenal dysfunction. Dehydration has been very rarely observed in the previous studies.

Reactions at the injection site were seen in patients receiving lixisenatide.

Although uncommon, allergic reactions had occurred in patients receiving lixisenatide (seedetails of allergic reactions signs mentioned above in this document).

These events were also seen with clinical use of similar drugs belonging to the same class(GLP-1 receptor agonists).

Immediately talk to you study doctor, if you experience severe and persistent abdominal pain,back pain or vomiting, alone or in combination. These could be signs of a serious medicalcondition named pancreatitis. Drugs similar to lixisenatide have caused pancreatitis in somepatients. Your blood tests will be routinely monitored for this but you should also report any

symptoms of abdominal pain to the study doctor.

In case of hypoglycemia (low blood sugar) you may feel the following symptoms: sweating,rapid heartbeat, hunger, tremor (shaking), fatigue, headache, restlessness, anxiety, irritability,mood change, trouble concentrating, blurred vision, dizziness, light-headedness or drowsiness.In severe cases, unconsciousness or fainting can occur and you may require the assistance ofanother person. Hypoglycemia can be treated by eating or drinking carbohydrates (for example

juice, raisins, sugar candies, or sugar tablets) according to the recommendations given by yourdoctor. In case you experience the above mentioned signs and symptoms, you are requested tomeasure your blood sugar with the glucose meter before eating, as soon as possible after theevent has occurred, and record its value in the diary.

There is a possibility that your body produces antibodies to lixisenatide (substances that actagainst lixisenatide). Overall, there is no difference in the safety profile of lixisenatide in patientswho developed antibodies and those who did not develop antibodies, with the exception of anincrease of the incidence of injection site reactions.

There may be other risks, when the study drug is taken alone or in combination with othermedications, that are unknown.

Placebo: placebo is not an active substance and should not have any side effects. Howeveryou should tell your study doctor about any symptoms that could develop during the study.

STUDY PROCEDURES

Visit 1 (screening)You will be asked to read and sign this consent document before any study-specific tests orprocedures are performed, if you wish to participate in this study. The following tests andprocedures will be performed:

The study doctor (or a member of his team) will question you about:o Your surgical, medical, diabetes, allergy and cardiovascular history as well as

your familial medical history, your past and present use of medications, alcoholconsumption, smoking status, age, gender and ethnic origin.


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o Your height and weight will be measured and recorded. A physical examination and electrocardiogram (ECG: displays the electrical activity of

your heart) will be performed. A blood sample will be taken and you will be asked toprovide a urine sample.

The study doctor will ask you if it is possible for you to complete 2 specificquestionnaires:

o MNA (Mini Nutritional Assessment) to assess if you are malnourished or at riskfor malnutrition

o MMSE (Mini Mental State Examination) to assess your cognitive status, in orderto check if you are eligible to participate in the study according to thesequestionnaires scores.

If for any reason you cant complete the questionnaires at this visit, the study doctor will ask youto come two weeks later to complete these two questionnaires.

You will be asked to provide additional contact information, such as an alternate phone number,

email address, family and/or friends contact information. These contacts will be used only in theevent that the study doctor loses touch with you during the course of the study and needs tolocate you to determine your health status. The study doctor will not give this information to thesponsor.

Visit 2If you did not complete the questionnaires at visit 1, you will return to the study doctors officewithin 2 weeks for your next visit. The following tests and procedures will be performed:

Completion of MNA and MMSE questionnaires if they were not completed at Visit 1. You will be asked if there have been any changes to your health or medications since

your last visit. Measurement of your weight and vital signs (heart rate and blood pressure)

Visit 3 (about 1 week after Visit 2):You will return to the study doctors office within about a week for your next visit. The followingtests and procedures will be performed:

You will be asked if there have been any changes to your health or medications sinceyour last visit.

Measurements of your weight and vital signs (heart rate and blood pressure) If your laboratory results are within the eligibility criteria, you may be qualified to start the

next phase (run-in period) and will be provided with a blood glucose meter, the suppliesthat go along with it (for example, needles, strips, etc) and a diary.

The study doctor or study staff will teach you at this visit and throughout the run-in:o How to use the glucose meter to accurately self-measure your blood sugar and

how to correctly record the values in your diaries.o How to recognize hypoglycemia symptoms, how to manage this condition and

how to record these events in your diaries. You will also receive from this visit on throughout the run-in period: life style and diet

advice.

Additional training will be available during study visits and any time you may have questions.


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From this visit onwards you should measure your blood sugar at home 1 to 3 times a week (3times a week if you are taking insulin) before breakfast and before you take any antidiabeticmedication. If you have any symptoms of hypoglycemia (low blood sugar) you will also be

instructed to measure your blood sugar levels and record the value in your diary. Allmeasurements should be recorded in the diary provided to you. You will also need to record inthe diary details of the dose and time of your anti-diabetic therapy (including the study drug) andany symptoms of hypoglycemia (low blood sugar). The diary also includes sections where youcan record any other relevant health problems or symptoms.

A Patients card (with emergency contact information) will also be provided.

Visit 4 (run-in period)Telephone contact at a scheduled time (about 1 week after visit 3) of about 15 minutes duration(interview to assess your health status, discuss your self-measured blood sugar valuesmeasured at home), record low blood sugar episodes, any other relevant health problems or

symptoms (side effects) you may have and new or change in medications you may have taken.

Visit 5 (run-in period)You will return to the study doctors office within about a week for your next visit. The following tests and procedures will be performed:


Measurements of your weight and vital signs (heart rate and blood pressure)

You will be provided with a placebo disposable self-injector pen and you will be trained to self-inject the product subcutaneously once a day 30-60 minutes before breakfast during a period ofone week or two weeks if needed. You will be asked to self-inject placebo at home once a day

30-60 minutes before breakfast with self-injector pen until the next visit as well as completingyour diary.

Visit 6 (run-in period)You will return to the study doctors office within about a week for your next visit. Please do noteat or drink anything (except water) 8 hours before coming to this visit. The following tests andprocedures will be performed:


Measurements of your vital signs (heart rate and blood pressure) Blood samples will be taken for laboratory testing You will be given a container and instructed to collect your first morning urine on the

morning of your next visit.

Your HbA1c value will be measured (a test to determine whether your blood sugar levels arewell controlled).

Depending on your current medications and the results of your HbA1c test, the study doctor willreduce the treatment doses in order to avoid occurrences of low blood sugar when starting thetreatment with the study treatment. In this case, one day prior or on the date of randomization, a


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research team member will call you and ask you to reduce your basal insulin dose by 20% oryour sulfonylurea (an oral medication) dose by 25% from the day before visit 7.

Your study doctor will check your compliance to the study treatment, to be eligible for the

treatment period you should not miss your daily injection.

At this visit you will also be asked to complete a questionnaire to assess your quality of life andto perform a meal test.

Between this visit and the next you will be asked to record your 7-point self-monitored bloodsugar levels (SMPG profile) using your glucose meter. This requires you to record your glucosevalues at the following time points during a 24 hour period (before and 2 hours after breakfast;before and 2 hours after lunch; before and 2 hours after dinner; at bedtime)all results shouldbe recorded in your patient diary:

Visit 7 (start of the treatment period with the study treatment, Day 1)

Eligibility criteria including HbA1c measured at the previous visit will be checked.If your laboratory tests are in the eligibility range and the other eligibility criteria are met, youenter the randomized treatment period. You will be assigned by chance (like the flip of a coin) toone of the two groups and will start the treatment with lixisenatide or placebo on top of yourprevious treatment.

After Visit 7, approximately every 2 weeks there will be either a phone call or a visit onsite (with 7 visits on site and 8 phone calls).

The last visit on treatment is Visit 22(Week 24 of the randomized treatment period).

About 3 daysafter this visit you will have a phone visit (Visit 23) which will be the last visit in the

study (end of study visit).

For the on-site visits (Visits 1, 2, 3, 5, 6, 7, 9, 11, 13, 15, 18, 21 and 22), you are asked tocome to the study site in the morning approximately at the same time.

For Visits 1, 6, 7 ,11, 15 and 22 pleasecome after a fasting period of at least 8 hours(during this time, you are only allowed to drink water); please do not inject study treatment orbasal insulin (if you take this treatment) and do not take your oral anti-diabetic treatmentat home the morning of the these visits. Please come to the study site with the diary, theblood glucose meter and the used and in-use pen-injectors. At specific visits (the study site staffwill let you know which visits) you will also bring unused pens.

A repeat 7-point SMPG profile needs to be performed over a single-24 hour period on a singleday during the week prior to Visit 22 (week 24) and all information recorded in your diary.

During the study, blood samples will be taken at 6 visits. Your blood pressure and heart rate willbe measured and recorded at every fasting on-site visit. Your weight will be measured at eachon site visit (except V5, V6 and V21) and you will be asked about your health condition andabout all medication you are using.


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Unscheduled visitsThere is a possibility that you may be asked to return to the clinic between the routine studyvisits, for an unscheduled visit. Possible reasons for these visits include, but are not limited tothe following:

Review of the laboratory or study procedure results Your study doctor or the sponsor may decide that an additional lab or study procedure

should be completed before your next visit.

Blood and urine samplesIn total, approximately 86.5 mL (corresponding approximately to 18 teaspoons) blood will bedrawn until visit 22 for laboratory testing including fasting blood sugar, Hemoglobin A1c,hematology, chemistry of the blood, Calcitonin (a marker for the thyroid gland), blood fats,testing for inflammation of the liver, renal function. If you test positive for hepatitis, your studydoctor may report this to the local health authority if required by local laws. If you are not takingbasal insulin, fasting insulin and 2 hours after breakfast will be measured two times during thestudy (the days of the meal test) to assess the sensitivity of your body to insulin and also the

function of you beta cells (cells in your pancreas that produce insulin in your body).

There will be also an assessment of lixisenatide antibodies (to see if your body has developedantibodies against lixisenatide) three times during the study.

In order to assess how lixisenatide is absorbed, distributed and eliminated from your body,pharmokinetic (PK) assessment will be done two times during the study.

Urinechemistry and excretion of protein (albumin) in the urine will be investigated.

Meal TestIn addition to the procedures described above, you will be asked 2 times, at visits 6 and 22 to

take a liquid standardized breakfast meal test. On these days, while on site, you will consume aspecial breakfast (a drink, to be taken within 15 minutes) and blood will be collected 3 times(before the injection of lixisenatide or placebo, at the start of the meal test, and 2 hours after thestart of the meal), to see how your blood sugar goes up and down with meals.

It is very important for the validity of this meal test that you come to the investigational sitefasting and with no antidiabetic treatment intake or basal insulin or study treatment injections athome.

Nutritional/frailty status, cognitive status and quality of life assessments:While on site, you will be asked to answer two questionnaires and complete one questionnaireat some visits:

Mini Mental State Examination (MMSE):Is a questionnaire to assess cognitive status (yourstate of mind), it has a 30 points maximum score. It will be performed with your study doctoronce at screening (visit 1or visit 2), to see if you are eligible to the study (you need to have ascore > 24) and a second time at Visit 21.


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Mini-Nutritional Assessment (MNA):Is a questionnaire to assess nutritional and frailty status.The full MNA includes 18 items and the short form MNA-SF includes 6 items and takes5 minutes to be performed and the full form MNA includes 18 items and takes less than 15

minutes. MNA-Short Form will be performed with your study doctor once at screening (visit 1 orvisit 2), to see if you are eligible to the study (you need to have a score > 12) and a second timeat Visit 21. If at this visit your score is < 12 you will have to continue on the full form MNA tounderstand why your previous score (at screening visit) did decrease.

Quality of life SF-12:it is a 12 items questionnaire to assess your quality of life, that you haveto complete by your own in a quiet place without the influence of a third part (study doctor,family members, friendsetc) and return it in a sealed envelope to the study doctor or his/herdesignee on the same day. You will complete this questionnaire two times during the study atvisit 6 (1 week before entering the study treatment period) and at visit 21.

Dispensing of Study Medication

If, based on the results of some of the tests and procedures, you qualify to participate in thestudy, study medication will be given to you at Visit 7 to self-inject once a day 30-60 minutesbefore breakfast. On the morning that you have a visit to your study site please do not injectyour study medication before the visit. Please store your unused study medication in your fridge.Once you have started to use a study drug pen it can be stored at room temperature

You will be randomly assigned (by chancesimilar to the flip of a coin) to receive eitherlixisenatide or placebo. You have a 1 in 2 chance of receiving study drug. At randomization thestarting dose is 10 micrograms per day (lixisenatide or placebo). After 2 weeks the dose will beincreased to 20 micrograms (lixisenatide or placebo) per day, if well tolerated. The 10microgram dose will be given to you in a pre-filled green colored self-injection pen; the 20microgram self-injector pen is purple colored.

If the dose of 20 micrograms is not tolerated, you will return to a dose of 10 micrograms per day,another attempt to increase the dose to 20 micrograms per day will take place before Visit 13. Ifafter Visit 13 (8 weeks of treatment) you still do not tolerate the dose of 20 micrograms per dayyou will remain at a dose of 10 micrograms per day until the end of the study.

This study is double blind which means that neither you nor your study doctor will know whetheryou are receiving study drug or placebo. However, your study doctor can get this information ifneeded in an emergency.

Medications Other than Study Medication (Concomitant Medications)

Before taking any medication, including over-the counter medications, you must discuss takingthese medications with your study doctor. Some medications may interact with the studymedication. This includes, but is not limited to, prescription medications and over-the-countermedications such as cough and cold remedies, pain relievers, antacids and any vitamins orherbal preparations. Use of these medications can also affect your medical test results andcould cause you to be discontinued from the study. Your study doctor will let you know aboutthe medications that you may or may not take while participating in this study. Use of illegal


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drugs during participation in this study is strictly forbidden and will result in you beingdiscontinued from this study.

The following drugs are not permitted during the screening and the double-blind treatment

periods: Any anti-diabetic treatment other than the study drug (Lixisenatide) and the allowed

background therapy. Allowed therapy includes:o Metformino Sulfonylureas (glipizide, glyburide, glimepiride)o Meglitinides (Starlix, Prandin)o Pioglitazone (Actos)o Basal insulin (Levemir, Lantus)

Initiation or modification of weight loss drugs. Previous treatment with weight loss drugscan be continued but the doses must remain stable throughout the study

Short/fast-acting insulin, or premix insulin therapy during the entire study except short-time use (such as 8 days at maximum due to acute illness or surgery)

Systemic glucocorticoid use, except if less than 10 days, and topical or inhaledapplications

During the post-treatment follow-up period, or if rescue medication is needed during the 24-week treatment period, any treatments other than GLP-1 receptor agonists or DPPIV arepermitted, as deemed necessary by the study doctor.

POTENTIAL RISKS AND DISCOMFORTSAll drugs have the possibility of complications and undesirable side effects that are unknown atthis time and could possibly occur. When taking the study drug alone or in combination withother medication, there may be other risks that are unknown.

Allergic Reaction RisksAs with taking any drug, there is a risk of allergic reaction. If you have a very serious allergicreaction, you may be at risk of death. Some symptoms of allergic reactions are:

Rash/hives. Itching. Shortness of breath, difficulty breathing, and wheezing. A sudden drop in blood pressure, dizziness, loss of consciousness. Swelling around the mouth, tongue, throat, or eyes. A fast pulse. Sweating.

If you think you are having an allergic reaction, you should immediately seek medical help.

Please seek treatment immediately and tell the study doctor and study staff if you have any ofthese symptoms, or any other side effects, during the study.

Electrocardiogram (ECG) RisksYou may have a mild rash at the place on your chest where the electrodes (which are softpatches) were attached. This rash usually goes away without treatment.


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POTENTIAL BENEFITSThere is no guarantee that you will benefit from participating in this study. It is possible thatyour type 2 diabetes may get better, stay the same, or get worse. If you take part in this study,other people with type 2 diabetes may be helped in the future.

During this study, you will benefit from a medical follow-up and be treated as appropriate foryour medical condition as if you were not participating in the study. At the beginning of thestudy, and every three months along the study, the study doctor or a member of his team willwork with you as necessary to adapt your diet, taking into account your food habits, and provideyou with lifestyle change counseling.

ALTERNATIVES TO PARTICIPATING IN THIS STUDYYou do not have to participate in this study to receive treatment for your condition. Your studydoctor will discuss the risks and benefits of other treatments with you before you decide whether

or not you want to participate in this study.

There are several other treatment regimens available to treat Type 2 diabetes. Should you notparticipate in this study, your routine treatment regimen will continue. If you have any questionsconcerning alternative options please direct your questions to the doctor conducting the study orto your primary doctor. You and your primary doctor can decide what treatment is best for you

COMPENSATION AND TREATMENT FOR INJURYIf you become ill or are hurt while you are in the study, get the medical care that you need rightaway. Any injury believed to be caused by the study drugs must be reported promptly to thestudy doctor.

In the event of a physical injury resulting directly from your taking part in the study, payment willbe limited to medical expenses for illnesses and injuries you experience as a result ofparticipating in this study, as long as you follow all instructions of the study doctor. Be awarethat your health care payer might not cover the costs of study-related injuries or illnesses.

There are no plans to provide other compensation beyond what is listed in this informed consentdocument. You will not lose any of your legal rights or release the sponsor, the study doctor,the study staff, or study site from liability for mistakes or intentional misconduct by signing thisconsent document.

You still have the right to make a claim through the legal system even if you sign this form,accept medical care, or accept payment for medical expenses.

COSTSThere will be no charge to you for your participation in this study. The study medication, studyvisits and study procedures will be supplied at no charge to you or your insurance companyduring the course of the study. For some conditions certain medications are routinely used aspart of treatment, such medicines may be considered background or standard therapy and arenot investigational, therefore are not provided as part of the study.


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CONFIDENTIALITYBy signing this form you are giving permission for your health data to be used by certain peopleand organizations. Certain people and organizations will need to see, copy, and use yourhealth data so that they can do their part in the study. They are called authorized users.

Authorized users will be given access to and make copies of your health data. This health datamay or may not include your name. It may be traced back to you even if it does not include yourname. You have some access rights to your data and the possibility to request that anyincorrect data be corrected according to local law and procedures.

Authorized users may include: The study doctor and study staff Institutional Review Board of Mercy Medical Center (IRB) Representatives of Sanofi The Food and Drug Administration (FDA) and other U.S. governmental agencies. Government agencies to whom certain diseases (like HIV, hepatitis, and STDs) must be

reported. Governmental agencies of other countries. Labs working with the sponsor on this study.

The study doctor, the sponsor or persons working on behalf of the sponsor, and under certaincircumstances, the United States Food and Drug Administration (FDA) and the InstitutionalReview Board of Mercy Medical Center (IRB) will be able to inspect and copy confidential study-related records which identify you by name. Therefore, absolute confidentiality cannot beguaranteed. If the results of this study are published or presented at meetings, you will not beidentified.

In addition, your health information collected during this study may be added to researchdatabases and used in the future by the sponsor, its affiliates, and licensing partners to developa better understanding of the safety and effectiveness of the study drug, study other therapiesfor patients, and improve the efficiency, design and study methods of future research studies.

For your safety, the study doctor should tell your regular health care provider that you are in thisstudy. You have an option to choose whether or not your regular health care provider iscontacted.

You will read more about the privacy of your data at the end of this form, called the HIPAAAuthorization Agreement.

COMPENSATIONDuring your participation you will receive a travel allowance to offset the cost of attending theresearch site visits. You will receive $40 for each completed site visit starting with Visit 1. Thiswill amount to a total $520 if all 13 office visits are completed. If you do not finish the study, youwill be paid for the part of the study that you did complete.


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EMERGENCY CONTACT / IRB CONTACTDuring the study, if you experience any medical problems, suffer a research-related injury, orhave questions about the study, please contact the study doctor at the telephone number listedon page one of this consent document. If you seek emergency care, or hospitalization is

required, alert the treating physician that you are participating in a research study beingconducted by the study doctor listed on page one of this document.

If you have any questions about your rights as a research subject, or complaints regarding thisresearch study, you should call or write the Chairman of the Mercy Medical CentersInstitutional Review Board, 1111 6thAve. Des Moines, IA 50314, (515) 247-3985. The MercyMedical Center Institutional Review Board is an independent committee established to helpprotect the rights of research subjects.

If you have any questions about the privacy or confidentiality of your medical information youshould contact: Privacy Officer of Mercy Medical Center at 515-643-4557.

A description of this clinical trial will be available onhttp://www.ClinicalTrials.gov,as required byU.S. Law. This Web site will not include information that can identify you. At most, the Web sitewill include a summary of results. You can search this Web site at any time.

VOLUNTARY PARTICIPATION / WITHDRAWALYour participation in this study is voluntary. You may choose not to participate or you maydiscontinue your participation in the study at any time without giving a reason and withoutpenalty or loss of benefits to which you are otherwise entitled and without any effect on yourfuture medical care.

The study doctor or sponsor may remove you from the study without your consent for any of the

following reasons: if it appears to be medically harmful to you, if you fail to follow directions for participating in the study, if it is discovered that you do not meet the study requirements, at the discretion of the study doctor or sponsor, if the study is canceled, or for administrative reasons, including competitive enrollment - the targeted number of

subjects has entered the treatment phase.

If you choose to withdraw from the study or if you are asked by your personal doctor to leavethe study, you must notify your study doctor immediately.

If you withdraw or are removed from the study, for any reason, your study doctor will ask you tohave a final evaluation. This evaluation could include any of the assessments/tests previouslymentioned in this document and any other procedures that the study doctor feels are medicallynecessary. In addition, if you withdraw or are removed from the study for any reason, yourdoctor may continue to review and provide your medical information to the study sponsor. Nonew study procedures will be conducted. The confidentiality and privacy of your information willbe protected as described earlier. You may also be contacted regarding your health status evenafter your final evaluation.
http://www.clinicaltrials.gov/http://www.clinicaltrials.gov/


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If you withdraw or are removed from the study, for any reason, you must return all studymedication given to you. This includes empty packets and any unused study medication. Youwill also need to return your glucose meter and diary.

SUBJECTS RESPONSIBILITIESYou must carefully follow any instructions given to you concerning the study and follow yourtreatment as instructed by your doctor. During the entire study, it is required that you takelixisenatide or placebo as prescribed in addition to your previous antidiabetic treatment, use theglucose meter according to the instructions and follow the dietary and physical activity advices.

While involved in this study, you should not start other new therapies for diabetes. If you enterthe study, your doctor will discuss with you whether you should stop or continue any therapiesyou may be taking.

You will be asked throughout the study about any medical or physical events that you may

experience while on study medication, as well as any other medications or treatments you mayhave taken. For any illnesses or injuries, you should contact the study doctor immediately or inany emergency situation, seek appropriate care.

PERMISSION TO COLLECT YOUR HEALTH INFORMATION IF YOU STOP HAVING STUDYVISITSBy signing this consent form, you are giving permission for the study doctor, study staff, andsponsor, to keep in contact with you, or (if you agree) someone who knows you, until the end ofthe study.

Should you choose to stop taking your study drug, you have numerous options for continuedfollow up, including:

Follow up visits to your study doctors office Follow up phone calls from your study doctors office to discuss your health and medical

changes Allowing your study doctor to obtain and follow your medical records.

If for any reason you choose to stop taking active study drug, your study doctor will discuss theabove options with you.

If you want to allow study-related contact with someone who knows you, please also provide thedetails of two people you know well (ideally one of these should be a health-care professional).


15/17


Annual Renewal

APPROVAL


Date: 5/17/2013

CONSENTIn giving my consent, I acknowledge my participation in this research study is voluntary, and Imay refuse or withdraw from participation at any time without penalty or loss of benefits to whichI am otherwise entitled. My signature below means I have read this consent document. I

understand its contents, and all my questions concerning this study have been answered by thestudy doctor and study staff. I will not lose any of my legal rights by signing this consentdocument. I will receive a copy of this signed and dated consent document.

By signing below, I agree that I would like to participate in the study.

________________________________________Subjects Name (Print)

________________________________________ ________________________Subjects Signature Date

________________________________________Name of Authorized Study Person AdministeringInformed Consent (Print)

________________________________________ _________________________Signature of Authorized Study Person Administering DateInformed Consent


16/17


Annual Renewal

APPROVAL


Date: 5/17/2013

AUTHORIZATION TO USE AND DISCLOSE PERSONAL HEALTH INFORMATION

A privacy rule has been issued to protect the privacy rights of patients. This rule (the PrivacyRule) was issued under a law called the Health Insurance Portability and Accountability Act of

1996 (HIPAA). The Privacy Rule is designed to protect the confidentiality of your healthinformation and requires your written permission for your identifiable health information to beused in this study. This section, called an Authorization, explains how your health informationwill be used and disclosed during this study and describes your rights, including the right to seeyour health information.

Permission to Review, Use, and Release Information about YouIf you decide to be in this study, the study doctor and study staff will use and share health dataabout you to conduct the study. Health data may include:

Your name. Address. Phone number. Date of birth. Medical history. Information from your study visits and test results (including the results of the HIV,

hepatitis, and recreational drug tests).Health data may also come from your study records or from existing records kept by yourregular doctor or other health care workers.

All information authorized to be released during this study may include records thatindicate the presence of a communicable or noncommunicable disease.For this study, the study doctor and study staff may share health data about you with authorizedusers. Authorized users may include:

The study doctor and study staff. The Study Sponsor Sanofi and its affiliates, assigns, and successors Representatives of Institutional Review Board of Mercy Medical Center (IRB) (a

research ethics review board that reviews this study). FDA and other U.S. governmental agencies. Government agencies to whom certain diseases (like HIV, hepatitis, and STDs) must be

reported. Governmental agencies of other countries. Labs working with the sponsor on this study.

The study doctor or sponsor may use some facts about your being in this study in books,magazines, journals, and scientific meetings. If this happens, no one will use your name or

other information that could be used to identify you.

If you sign this form, you allow the study doctor to share your records with your health carepayer to resolve your claim if you are hurt because of being in this study. If this happens, thestudy doctor or the sponsor may share your records with their insurance carriers to resolve yourinsurance claim, and the study doctor may also request medical records from your other healthcare providers to learn more about your condition.


17/17


Annual Renewal

APPROVAL


Date: 5/17/2013

Once your health data has been shared with authorized users, it may no longer be protected byFederal privacy law. The sponsor or others may share your records with other people who donot have to protect the privacy of your records.

You may take back your permission to use and share health data about you at any time bywriting to the study doctor. If you do this, you will not be able to stay in this study. No newhealth data that identifies you will be gathered after your written request is received. However,health data about you that has already been gathered may still be used and given to others asdescribed in this form.

During the study, the study doctor or study staff may find new medical information about you.The study doctor or study staff will share this with you right away if it is important to your health.The study doctor or study staff may advise you to get other tests to check this new information.Your right to access (see and copy) your health data in the study records will be suspendedduring the study to keep from changing the study results. When the study is over, you canaccess your study health data.

If you do not sign this Authorization, you cannot participate in the study. If you cancel thisAuthorization in the future, you will no longer be able to participate in the study.For further information regarding cancellation, see the VOLUNTARY PARTICIPATION /WITHDRAWAL section above.

This Authorization does not have an expiration date. By signing below, you allow the studydoctor to use or disclose your Personal Health Information as described above.

You will receive a copy of this Authorization after you have signed it.

___________________________________Printed Name of Subject

___________________________________ ______________Signature of Subject Date

____________________________________Printed Name of Person Obtaining Authorization

____________________________________ ______________Signature of Person Obtaining Authorization Date

GetGoalOEFC12703StampedApprovedICF5-17-13

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