Clinical trial NCT03782259
Conditions: Type 2 Diabetes Mellitus Myocardial Fibrosis Myocardial Inflammation
Sponsor: University of Washington
Start date: 2019-02-26; Completion date: 2022-11-16
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There is an unmet need for Cardiovascular Disease (CVD) risk reduction in patients with Type 2 Diabetes. In recent trials there has been promising findings of more effective glucose management and reductions in overall CVD events and hospitalization for heart failure with SGLT-2 inhibition. Using the capability of cardiac MRI with T1- and T2-mapping in assessments of myocardial fibrosis and inflammation, the investigators propose to conduct a clinical trial to investigate the effects of SGLT-2 inhibition with dapagliflozin on myocardial strain, fibrosis and inflammation as assessed by cardiac MRI with T1- and T2-mapping in patients with type-2 diabetes.

Over approximately 12 months subjects will have 6 clinical visits at the investigators research clinic. During this time subjects will be randomized to receive either active 10mg dapagliflozin or a matching placebo. 2 MRI scans at one of the two University of Washington research imaging centers will take place. One at randomization and the second scan will occur approximately 12 months after the first scan.

Detailed description:
Given the unmet needs for CVD risk reduction in patients with Type 2 Diabetes Mellitus (T2DM), the promising findings of more effective glucose management and reductions in overall CVD events and hospitalization for heart failure with SGLT-2 inhibition demonstrated in recent trials, and the capability of cardiac MRI (CMRI) with T1- and T2-mapping in assessments of myocardial fibrosis and inflammation, the investigators propose to conduct a staged research program using adaptive study design to investigate the effects of SGLT-2 inhibition with dapagliflozin on myocardial strain, fibrosis and inflammation as assessed by cardiac MRI with T1- and T2-mapping in patients with type-2 diabetes.

A total of 60 subjects with \>=18 years of age, type-2 diabetes history \>=5 years and HbA1C 7-10% will be randomized at 1:1 to Dapagliflozin 10mg or matching placebo once daily for 1 year. All subjects will be followed every 3 months for clinical and laboratory evaluations and assessments. All subjects will undergo CMRI at baseline and 1 year.

The primary myocardial strain endpoint includes global myocardial longitudinal strain (GLS). Myocardial fibrosis endpoint is change in extracellular volume fraction (ECV) as assessed by T1-mapping over 12 months. ECV combines native and contrast-enhanced T1 mapping. The change of the T1 relaxation rate (i.e., 1/T1) in blood between pre- and post-contrast imaging is converted with the blood hematocrit into a reference for plasma T1, which serves as reference for the T1 changes in tissue.

Arms: arm 1: 10mg tabs placebo matching dapagliflozin. arm 2: 10mg tabs of dapagliflozin
Interventions: intervention 1: dapagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will either receive 10mg tabs of dapagliflozin or identical looking placebo - inactive medication. Subjects have an equal chance of receiving dapagliflozin or placebo. Which treatment subjects receive is decided at random by a computer (purely by chance, like the tossing of a coin). Neither subjects nor the Study Site personnel will know which treatment subjects are assigned to. The study drug must be taken daily. The subject's other medications will not be changed by the study. intervention 2: Placebo

Protocol documents:
Prot_SAP_000.pdf: 







































































































ICF_001.pdf: 


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X-Q Zhao 
AZ SGLT2 MR Consent Form v5 
07DEC2020
P-555 / Consent Form Template, Standard, 01/12/2018 -  Version 8.9
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UNIVERSITY OF WASHINGTON
CONSENT FORM
Effects of SGLT-2 Inhibition with Dapagliflozin on Myocardial Fibrosis and Inflammation 
as Assessed by Cardiac MRI with T1 and T2 Mapping in Patients with Type 2 Diabetes
Researchers:
Xue-Qiao Zhao, MD Professor, Cardiology
206-744-8305
Susan McKeeth
Research Coordinator, Cardiology
206-744-8307
24-hour emergency telephone number - Dr. Zhao – 206-280-6173
Researchers’ statement
We are asking you to be in a research study.  The purpose of this consent form is to give you the 
information you will need to help you decide whether to be in the study or not.  Please read the 
form carefully.  You may ask questions about the purpose of the research, what we would ask 
you to do, the possible risks and benefits, your rights as a volunteer, and anything else about the 
research or this form that is not clear.  When we have answered all your questions, you can 
decide if you want to be in the study or not.  This process is called “informed consent.”  We will 
give you a copy of this form for your records.
PURPOSE OF THE STUDY
We would like you to be part of this study to examine the muscle of your heart.  We are asking 
you to be in this study because you have been diagnosed with Type 2 Diabetes.  A number of 
studies have shown that over time heart muscle cells can become stiff (myocardial fibrosis); this 
is one of the main reasons for cardiac dysfunction (cardiomyopathy).  The purpose of this study 
is to look at whether a type of diabetes drug, SGLT-2 inhibitor dapagliflozin, will help keep 
heart muscle from becoming stiff.  We will use MR imaging before taking the drug and after 1 
year of the drug to watch for changes.  We plan to enroll at least 60 subjects in this part of the 
study and will enroll 30 subjects to serve as controls for the research blood samples.
Magnetic resonance imaging (MRI) uses radio waves from a large magnet and the body’s 
response to the radio waves to create pictures of the inside of the body.  In this study, we will 
look at the cells of the heart muscle by using standard MRI and magnetic resonance angiography 
(MRA).  MRA is MRI with a contrast agent used to improve the pictures.  
The U.S. Food and Drug Administration (FDA) has approved the contrast and the diabetes drug 
that will be used in this study.  
STUDY PROCEDURES
Over approximately 12 months you will have 2 phone interviews, 6 clinical visits at our research 
clinic and undergo 2 MRI scans at one of the two UW research imaging centers (either the UW 
Bio-Molecular Imaging Center in South Lake Union or the UW Diagnostic Imaging Sciences 
Center at UWMC; BMIC or DISC).  Each center offers the same services; you will be 
scheduled based on availability.  The second scan will occur approximately 12 months after the 
first scan.


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X-Q Zhao 
AZ SGLT2 MR Consent Form v5 
07DEC2020
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Today’s Screening Visit, CARL @ Harborview
The initial screening visit will be at the Clinical Atherosclerosis Research Lab (CARL); this 
visit will last about 1 hour. You will be measured for blood pressure, height, weight, body 
temperature and waist circumference. You will be asked about your current health, medical and 
surgical history and if you are taking any medicines.
We will conduct a fasting blood draw to collect a small amount of blood (approximately 20mL 
or 4 teaspoons) to determine your level of kidney function and other relevant laboratories.  
Fasting is no food or drink beyond water for at least 10 hours.  The test for kidney function is 
called a creatinine test.  This test will determine if it is safe to inject the contrast agent into a vein 
in your arm as part of the MRI.  The other lab tests will include a cholesterol panel, fasting 
glucose, HbA1c as well as safety tests of AST, ALT, CPK and hsCRP which will give us an idea 
about any liver or heart disease.
Unlike CT scans or X-rays, MRI does not use radiation. Instead, it uses a powerful magnetic 
field to create images. You will be carefully screened with a series of questions to be sure you do 
not use or wear devices, implants or materials that could be damaged by the magnet, or cause 
damage to your body under the influence of the magnet.  Examples of questions we will ask you 
include: Do you have a pacemaker, stents, or aneurysm clips? Have you been hurt by shrapnel? 
Are you pregnant?
You may refuse to answer any question; however, if the research team is unable to collect the 
required information to verify your safety in the MRI you will be withdrawn from study 
participation.
The Clinic Visit 2 and Baseline MRI visit described below may occur in no particular order, or 
even the same day, to coordinate with MR Scanner availability and research laboratory analysis 
which requires specialized shared equipment.
Clinic Visit 2 – Baseline Clinic visit, CARL @ Harborview 
This is the day of randomization, which will take place only if you meet all of the inclusion 
requirements. The following procedures will be done:
•
Your pulse, blood pressure, weight and body temperature will be measured.
•
Fasting blood samples will be taken, (approximately 60mL or 4 tablespoons).  Additional 
plasma will be frozen at -80 degree and may be analyzed for exploratory biomarkers to 
assess correlations with disease activity, effects of study drug, clinical outcomes and 
toxicity. This draw will also include extra blood to be used for mitochondrial function 
assessment.
•
If you are a woman of childbearing potential you will provide a urine sample to test for 
pregnancy.
•
You will be asked about your overall health and whether you have had any problems, 
drug side effects, discomfort or hospitalizations since your last visit.


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X-Q Zhao 
AZ SGLT2 MR Consent Form v5 
07DEC2020
P-555 / Consent Form Template, Standard, 01/12/2018 -  Version 8.9
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•
You will be asked if you have had any changes in the medicines you take.
•
You will start taking study medication.
You will either receive 10mg tabs of dapagliflozin or identical looking placebo – inactive 
medication.  You have an equal chance of receiving dapagliflozin or placebo.  Which treatment 
you receive is decided at random by a computer (purely by chance, like the tossing of a coin). 
The term “study drug” refers to both dapagliflozin and placebo in this form. Neither you nor the 
Study Site personnel will know which treatment you have received. After the first dose, the study 
drug must be taken daily.  We will not ask you to make any changes to your other diabetes 
medications.  You will continue on your standard care with the addition of the study 
drug/placebo.  The study drug is yours and should not be taken by anyone else.
Baseline MRI visit, BMIC/DISC -  may occur ±14 days from Clinic visit 2 described above
The MRI will last about 1 hour. The MRI Technologist will review your answers to the safety 
questions and any related medical records to make sure it is safe to proceed. You will be asked to 
place personal items, such as credit cards, watches, and jewelry in a lock box before you enter 
the MRI scanner room.
If not completed for the study previously, and you are a woman of childbearing potential you 
will be asked to provide a urine sample to test for pregnancy.
You will then enter the scanner room.  Before the MRI scan begins, a small needle will be 
inserted into a vein in your arm or hand.  This is so that the contrast material can be injected later 
during the MRI scan.  The contrast will improve the pictures of the muscle cells.  The MR 
Technologist will place two ECG leads on your chest, stickers used to measure your heart beat, 
to “time” the cardiac scan.  A “coil” which acts as an antenna will be laid across your chest and 
held in place with a soft foam strap.  Scientists at the University of Washington (UW) have 
designed the computer program that runs the MRI scanner used for this study.
Throughout the MRI scan you will lie down on a flat movable bench.  The MRI magnet has a 
tube-like opening, and the bench will go into the opening, so that your body will be inside the 
magnet.  During the scan, you will hear a series of loud knocking and banging noises. You will 
be given earplugs to help quiet the noises.  You may speak through a loud speaker to the 
technologist at any time during the scan.  The technologist will let you know when it is best to 
clear your throat or move.  You may be asked to hold your breath for up to 30 seconds when the 
heart scan is taking place.  This will limit the amount of extra movement for the images.  Our 
research staff will follow the U.S. Food and Drug Administration (FDA) established safety 
guidelines for MRI.
First during the scan you will have images made without contrast.  Then during the scan, a small 
amount of gadolinium-based contrast material is injected.  The contrast is Gadavist®and the dose 
is based on your weight.
You may stop the exam at any time for any reason.


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X-Q Zhao 
AZ SGLT2 MR Consent Form v5 
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Telephone Interview
Approximately 2 weeks after starting the study drug we will contact you by phone to see how 
you are doing.  The following interview areas will be addressed:
•
You will be asked about your overall health and whether you have had any problems, 
drug side effects, discomfort or hospitalizations since your last visit.
•
You will be asked if you have had any changes in the medicines you take.
•
You will be asked about taking the study medication and if you have been having any 
trouble remembering or missed any days.
•
If you have had any health problems or adverse reactions to the study medications you 
will be asked to return to the study clinic for an Unscheduled Visit.  You may be 
instructed to stop the medication until you can be seen by the study team.
3, 6 and 9 month Clinic visits, CARL @ Harborview
We will ask you to return to the clinic for three visits to track any health changes.  The following 
procedures will be done:
•
Your pulse, blood pressure, weight and body temperature will be measured.
•
Fasting blood samples will be taken, (approximately  20mL or 4 teaspoons). 
•
You will be asked about your overall health and whether you have had any problems, 
drug side effects, discomfort or hospitalizations since your last visit.
•
You will be asked if you have had any changes in the medicines you take.
•
You will return unused study medication and medication bottles, whether they are empty 
or not, and you will receive a new supply of study medication.
Unscheduled Clinic visit, CARL @ Harborview
If you have a significant clinical event of interest to the study we will ask you to return to the 
clinic to meet with us and discuss the event and assess any health changes.  The following 
procedures will be done:
•
Your pulse, blood pressure, weight and body temperature will be measured.
•
Fasting blood samples will be taken, (approximately  20mL or 4 teaspoons). 
•
You will be asked about your overall health and whether you have had any problems, 
drug side effects, discomfort or hospitalizations since your last visit.
•
You will be asked if you have had any changes in the medicines you take.
•
You will return unused study medication and medication bottles, whether they are empty 
or not, and you will receive a new supply of study medication.
Final Clinic visit, CARL @ Harborview 
The following procedures will be done:
•
Your pulse, blood pressure, weight and body temperature will be measured.
•
Fasting blood samples will be taken, (approximately 70mL or 5 tablespoons).  Additional 
plasma will be frozen at -80 degree and may be analyzed for exploratory biomarkers to 
assess correlations with disease activity, effects of study drug, clinical outcomes and 


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X-Q Zhao 
AZ SGLT2 MR Consent Form v5 
07DEC2020
P-555 / Consent Form Template, Standard, 01/12/2018 -  Version 8.9
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toxicity. This draw will also include extra blood to be used for mitochondrial function 
assessment.
•
You will be asked about your overall health and whether you have had any problems, 
drug side effects, discomfort or hospitalizations since your last visit.
•
You will be asked if you have had any changes in the medicines you take.
•
You will return unused study medication and medication bottles, whether they are empty 
or not.
•
You will fill out a new MRI Screening form to ensure no changes have taken place that 
affect your ability to participate in the MRI.
Final MRI visit, BMIC/DISC -  may occur up to 14 days from Final Clinic visit described 
above
The MRI will last about 1 hour. The MRI Technologist will review your answers to the safety 
questions and any related medical records to make sure it is safe to proceed. You will then 
undergo the exact same MRI scan procedure as before.  
You may stop the exam at any time for any reason.
Telephone Follow-up Call
We will call you approximately 2-4 weeks after you have completed the final MRI to again ask if 
you have had any health changes since stopping the study.  This brief (about 15 min) phone call 
will mark the end of the study.
In total the study will take approximately 8 hours of your time over the year and daily study 
medication compliance.  The blood tests described above will require approximately 20-70mL 
each time, a total of approximately 210mL which is about 1 cup.
CARL @ Harborview
BMIC or DISC
Study 
Visit 
Summary 
Table:
Consent, 
MRI 
Safety Screening, 
medical history
Study 
drug 
dispensing
Health event 
& side effect 
assessment
Vital signs, 
blood 
sample
Review MRI Safety 
and complete 
MRI Scan
Screening Visit, Today
Yes
Yes
Baseline 
Yes
Yes
Yes
1st MRI visit
Yes
Telephone Interview
Yes
3, 6 and 9 Month visits
Yes
Yes
Yes
Final Clinic 
Yes
Yes
Final MRI
Yes
Telephone Follow-up call
Yes
Unscheduled Clinic Visit 
(only if necessary)
Yes
Yes
Yes


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X-Q Zhao 
AZ SGLT2 MR Consent Form v5 
07DEC2020
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Your contact information will be retained by the study team.  This is so we may ask you for 
additional information or medical record access that is not currently part of the approved study.  
For example, it may someday be scientifically valuable to send you a mailing or attempt a phone 
interview to ask about your health status and any clinical events after the final MRI scan visit.
RISKS, STRESS, OR DISCOMFORT
MRI:  There are no known side effects associated with magnetic resonance imaging.  However, 
having an MRI may mean some added discomfort for you. You may feel claustrophobic (“closed 
in”) when in the scanner. Lying still for up to 60 minutes may be uncomfortable. The MRI 
machine is loud; you may find the noise unpleasant. This is why we will ask you to wear 
earplugs, which are provided.  Because some coils can focus energy into a small part of the body, 
there is a remote chance you may feel warmth in some area of your body.  If this occurs, please 
tell us immediately. 
You and your primary care physician will be notified if the Investigators identify a potentially 
clinically significant finding during image review.  However, this study and MRI images are for 
research purposes only and are not clinical procedures.  Further clinical confirmation, evaluation 
and treatment plans will be left to you and your physician(s).  Additionally, although more than 
one individual will be reading the images it is still possible that a finding not related to heart 
muscle may be missed and the reviewers are not board-certified Radiologists therefore it may be 
the case that there are findings even if they are not identified by the reviewers.
MAGNET:  Because the MRI machine acts like a large magnet, it could move objects 
containing iron in the MRI room during your examination, which could possibly harm you. We 
will take precautions to prevent this from happening. Loose metal objects, like pocket knives or 
key chains, are not allowed in the MRI room. If you have a piece of metal in your body, such as 
a fragment in your eye, aneurysm clips, ear implants, spinal nerve stimulators, or a pacemaker, 
you will not be allowed into the MRI room and cannot have an MRI.
CONTRAST MATERIAL (GADOLINIUM):  The contrast material that will be used during 
the MRI study, Gadavist®, is a gadolinium agent that has been approved by the FDA.  The 
specific amount of contrast you receive will depend on your body weight.  As with any drug, 
there may be unanticipated side effects.  Some of the most frequent adverse events that have 
been reported during previous clinical use are nausea, headache, dizziness, metallic taste, warmth 
and tingling (occurred in less than 3% of patients).  Allergic responses including difficulty 
breathing, faster heart beats, or severe nausea has been reported in less than 1% of patients.  The 
small needle used to inject contrast might cause redness or bruising at the site of the injection.  
Throughout the MRI a physician is on-call and available to provide care, if necessary. 
Nephrogenic Systemic Fibrosis (NSF): In a very small percentage of patients who already have 
impaired kidney function, gadolinium-based contrast medium has been shown to cause a new 
disease, called nephrogenic systemic fibrosis, or nephrogenic fibrosing dermopathy (NSF/NFD). 


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AZ SGLT2 MR Consent Form v5 
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NSF is a debilitating and potentially fatal disease that involves the skin, muscle and internal 
organs.  This condition occurs exclusively in those who already have impaired kidney function.  
Only subjects with acceptable renal function 
will be recruited for this study.  If at your 
first visit your blood test reveals an impaired kidney function (eGFR<50) you will be withdrawn 
from the study and no MRI will take place, this will mark the end of your study participation.  If 
at one of the follow-up visits your blood test reveals an impaired kidney function (eGFR<45) the 
MRI scan can be safely performed without using the gadolinium-based contrast. As described, 
we will test your blood before each scan to assess your renal function.
The FDA has issued a safety communication indicating that gadolinium may be retained in the 
body long-term. The risks of this retention are unknown. To date, we have not seen any evidence 
that these small amounts of gadolinium cause health problems.  If there are any new findings, we 
will revise our guidelines for using gadolinium injections.
BLOOD SAMPLE: Each blood sample may cause the usual small discomfort and possible 
bruise at the site of needle puncture.
PREGNANCY: This study does not include pregnant women. If you are a woman of 
childbearing potential you will be asked to provide a urine sample for a pregnancy test prior to 
enrollment.  If you do not provide the sample you will be withdrawn from the study. If you are a 
woman of childbearing potential you must be willing to use a medically accepted method of 
contraception that is considered reliable in the judgment of the investigator, from the time of 
signing the informed consent until two weeks after the last dose of study drug.
STUDY DRUG  Farxiga® (dapagliflozin): Dapagliflozin works by eliminating sugar (glucose) 
from the body to help with blood sugar control in patients with Type 2 Diabetes.  The glucose is 
eliminated in the urine.  The drug can sometimes eliminate up to about 70 grams of glucose per 
day, this may result in rapid weight loss and/or tiredness. The glucose can act as diuretic causing 
frequent urination and could lead to dehydration or hypotension (low blood pressure). 
Symptomatic hypotension can occur after starting dapagliflozin particularly in patients with 
lowered kidney function (eGFR less than 60), patients aged 70 or above, or patients on loop 
diuretics (such as furosemide, bumetanide, torsemide, or ethacrynic acid). The increased amount 
of glucose in the urine can also increase the risk for and worsen the infections already associated 
with diabetes, particularly urinary tract infections and female genital fungal infections (like a 
yeast infection). Dapagliflozin has also been associated with an increase incidence of 
nasopharyngitis, which is swelling of the nasal passages and the back of the throat often 
experienced with the common cold and possibly leading to sinus infection.
Especially when added to other diabetic mediations, Dapagliflozin can lower blood sugar 
causing hypoglycemia with symptoms of shaking, sweating, fast heartbeat, dizziness, hunger, 
headache, and/or irritability. Hypoglycemia would require immediate treatment with taking in 
sugary food or drink and then checking your blood sugar. Make sure that you discuss with your 
care provider what to do if you have these symptoms.


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AZ SGLT2 MR Consent Form v5 
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The FDA has warned of rare but serious infection of the genitals and area around the genitals 
being reported with this class of drug.  This infection, called necrotizing fasciitis of the 
perineum, is also referred to as Fournier’s gangrene.  Although rare, we ask that you seek 
medical attention immediately if you experience any symptoms of tenderness, redness, or 
swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 
100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is 
important to seek treatment right away.
Only subjects with acceptable renal function 
will be recruited for this study.  
Dapagliflozin is approved for eGFR of 45 or higher.  If at your first visit your blood test reveals 
an impaired kidney function (eGFR<50) you will be withdrawn from the study and, this will mark 
the end of your study participation.  If at one of the follow-up visits your blood test reveals an 
impaired kidney function (eGFR<45) the study drug will be discontinued and you will be asked to 
return for an unscheduled visit to ensure your kidney function returns to your baseline level.  As 
described, we will test your blood before randomization and again at each visit to assess your 
renal function.  Studies have shown an increased risk of bone fractures in subjects with an eGFR 
between 30 and 60 mL/min/1.73m2 (compared to those receiving placebo).
Elevated LDL cholesterol (3%) is an infrequent adverse effect of dapagliflozin. Rare and serious 
adverse effects include hypersensitivity reactions (0.3% may develop any of these symptoms: 
hives, itching, shortness of breath, skin rash, and swelling of the mouth, lips, and tongue), 
ketoacidosis (0.3%), acute kidney injury (as a result of untreated, severe dehydration), and 
increased risk of bladder cancer.
Ketoacidosis is a serious condition that can lead to hospitalization and death. If you have 
symptoms of nausea, tiredness, vomiting, trouble breathing, and abdominal pain, call your care 
provider immediately.  They may check your blood or urine for ketones and stop your study drug 
if positive.
Should these or any other adverse effects from the medication occur, please contact the 
study team and/or your doctor as soon as possible for treatment options.
ALTERNATIVES TO TAKING PART IN THIS STUDY
The alternative to this study is not to participate. All medications used in our study are approved 
by the FDA and available with a prescription from a physician.
BENEFITS OF THE STUDY
You will not receive any medical benefits from taking part in the study. This study is for research 
only. This study is not meant to treat, diagnose, or prevent any disease.  However, your 
participation may help future patients with Type 2 Diabetes and heart disease.


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X-Q Zhao 
AZ SGLT2 MR Consent Form v5 
07DEC2020
P-555 / Consent Form Template, Standard, 01/12/2018 -  Version 8.9
9 of 11
SOURCE OF FUNDING
The study team and the University of Washington is receiving financial support and the study 
drug from AstraZeneca.
CONFIDENTIALITY OF RESEARCH INFORMATION
We will collect data for this study in a confidential manner.  Your identity will remain 
confidential. Your data will be given a unique code to protect your privacy.  The study 
coordinator will keep a document with your name, phone numbers, and the name and phone 
number of your doctor. This is so that we can contact you or your doctor if needed.  The results 
from this study will be used in scientific reports and presented at scientific meetings. They will 
not contain any information identifying you. We may use the images and study information for 
future studies. The images and information will not contain any information identifying you.
If you agree to take part in this study, we will access and review your medical records.  Records 
will be accessed to confirm your eligibility including information about your Diabetes diagnosis 
and treatment and any implants or operations that may exclude you from participating for safety 
reasons.  We may review hospital discharge summaries, radiology records, your medical history, 
operative reports (about an operation), and other records needed to verify MR compatibility of 
any foreign bodies and your Diabetes diagnosis.  
Dr. Zhao and her staff will have access to this information. They will have access to other 
information resulting from this study. If we cannot locate your records, we may contact you to 
help us find their location. 
Government or university staff sometimes review studies such as this one to make sure they are 
being done safely and legally.  If a review of this study takes place, your records may be 
examined.  The reviewers will protect your privacy.  The study records will not be used to put 
you at legal risk of harm.
The following people or groups may see information that identifies you as a participant in this 
study:
Members of Dr. Zhao’s research team
The University of Washington Institutional Review Board
State and Federal regulators
All data and samples collected, but without personal history information (name, date of birth, 
address, etc.) will be kept indefinitely so that they may be used in future studies. 
A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required 
by U.S. Law.  This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
Your participation in this study will be noted in your UW medical record.


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OTHER INFORMATION
You may refuse to participate and you are free to withdraw from this study at any time without 
penalty or loss of benefits to which you are otherwise entitled.
We may remove you from the study if you are found to be ineligible.  This could be due to 
medical record review, or laboratory or study visit evaluation at any of the visits, or if we cannot 
be certain that it is safe for you to participate. 
You may not take another SGLT2 Inhibitor class drug as this is a safety concern (drugs like 
canagliflozin (Invokana), empagliflozin (Jardiance) and ertugliflozin (Steglatro) work the same 
way).  You also may not take any other investigational drug.     If your physician requires one of 
these medications we will withdraw you from further study participation.  Please be sure to 
contact the study team if you have any questions about new prescriptions from your physician 
and if they may conflict with the study.
It will not cost you anything to be in this study.  You will receive a payment for taking part in 
this research study.  To cover travel costs and your time, you will receive $65 for each MRI scan 
visit and $20 for each clinic visit.  You will receive up to $210 for the scheduled visits.  If you 
have any extra clinic visit(s) you may receive $20 for each visit.  You will receive the $65 for the 
MRI visit whether or not you finish the scan.  Payment will be sent by mail to the address you 
provide.
We offer parking validation for subjects who park in one of Harborview Medical Center’s 
parking lots and at the MRI Facility.  Directions to these validated lots will be provided.
Neither you nor your insurance company will be charged for the following items:
•
Study drug
•
Study visits
•
Study procedures
•
Study laboratory tests
We will share the fasting glucose and HbA1c research results with you or your physician(s).  
Results can be sent by mail to the address you have provided.  To ensure timely and correct 
delivery please promptly let us know of any address changes.
RESEARCH-RELATED INJURY
If you think you have a medical problem or illness related to this research, contact Dr. Zhao, at  
206-280-6173 right away. She will refer you for treatment. 
It is important that you promptly tell the researchers if you believe that you have been injured 
because of taking part in this study. You can tell the researcher in person or call her at the 
number(s) listed at the top of this form. This number is monitored 24 hours a day.
For a life-threatening problem, call 911 right away or seek help immediately. Contact Dr. Zhao, 
at  206-744-8308 when the medical emergency is over or as soon as you can. 


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X-Q Zhao 
AZ SGLT2 MR Consent Form v5 
07DEC2020
P-555 / Consent Form Template, Standard, 01/12/2018 -  Version 8.9
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The costs of the treatment may be billed to you or your health insurance just like other medical 
costs, or it may be covered by the UW’s discretionary Human Subjects Assistance Program 
(HSAP), depending on a number of factors.  The researcher may request HSAP coverage by 
following established procedures. If you wish to request HSAP coverage yourself, contact the 
researcher or the UW Human Subjects Division at hsdinfo@uw.edu or 206-543-0098. You may 
also call collect to the UW Human Subjects Division at 206-221-5940 if you do not otherwise 
have access to a telephone. Ask the researcher if you would like information about the limits and 
conditions of the HSAP. The UW does not normally provide any other form of compensation for 
injury. However, the law may allow you to seek payment for injury-related expenses if they are 
caused by malpractice or the fault of the researchers. You do not waive any right to seek 
payment by signing this consent form. We will bill your health insurance for treating problems 
that result from your Type 2 Diabetes or from standard clinical care. If you have no health 
insurance or your insurance refuses to pay, we will bill you.
Printed name of study staff obtaining consent
Signature
Date
Subject’s statement
This study has been explained to me.  I volunteer to take part in this research.  I have had a 
chance to ask questions.  If I have questions later about the research, or if I have been harmed by 
participating in this study, I can contact one of the researchers listed on the first page of this 
consent form.  If I have questions about my rights as a research subject, I can call the Human 
Subjects Division at (206) 543-0098 or call collect at (206) 221-5940.  I will receive a copy of 
this consent form.
Printed name of subject
Signature of subject
Date
Copies to:
Researcher & Subject