Clinical trial NCT02433678
Conditions: Type 2 Diabetes
Sponsor: University at Buffalo
Start date: 2015-11-01; Completion date: 2018-11-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single center, prospective, randomized, placebo -controlled, parallel design and double blind study to evaluate oxidative stress, inflammation and hypertension markers and mediators before and after treatment with dapagliflozin.

Detailed description:
Two groups of 26 patients each (total 52 patients) with type 2 diabetes on oral agents will be included in the study. One group will be randomized to dapagliflozin (a dose of 5 mg daily will be titrated to 10 mg daily during the first week) while the other will be placebo. The patients will be treated for 12 weeks. Only half the patients (equal numbers in both groups) will be tested for the secondary endpoints related to postprandial and single dose induced changes. The primary endpoint of the study is to detect a significant difference in the percent change in fasting Nuclear factor-k B (NFκB) activation (DNA binding activity) in mononuclear cells (MNC) before and after dapagliflozin use (0 week vs. 12 weeks) as compared to placebo.

Arms: arm 1: Patients will be treated for 12 weeks with placebo once daily arm 2: 10 mg daily for the 12 weeks
Interventions: intervention 1: dapagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: SGLT-2 inhibitor for the treatment of type 2 diabetes intervention 2: None

Protocol documents:
Prot_000.pdf: 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federalwide Assurance ID#: FWA00008824 
Page 1 of 39 
 
 
An Investigation Into The Anti-hypertensive And Potential 
Anti-inflammatory Actions Of Dapagliflozin 
 
NCT number: NCT02433678 
 
Document date: 10/2/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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IRB Version: JAN2016 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions.......................................................................................................... 3 
1.0 
Objectives ................................................................................................................ 5 
2.0 
Scientific Endpoints ................................................................................................. 6 
3.0 
Background .............................................................................................................. 6 
4.0 
Study Design ............................................................................................................ 8 
5.0 
Local Number of Subjects ....................................................................................... 8 
6.0 
Inclusion and Exclusion Criteria .............................................................................. 9 
7.0 
Vulnerable Populations .......................................................................................... 10 
8.0 
Eligibility Screening .............................................................................................. 11 
9.0 
Recruitment Methods ............................................................................................. 12 
10.0  Procedures Involved ............................................................................................... 13 
11.0  Study Timelines ..................................................................................................... 17 
12.0  Setting .................................................................................................................... 18 
13.0  Community-Based Participatory Research ............................................................ 18 
14.0  Resources and Qualifications ................................................................................. 19 
15.0  Other Approvals ..................................................................................................... 20 
16.0  Provisions to Protect the Privacy Interests of Subjects .......................................... 20 
17.0  Data Management and Analysis ............................................................................ 21 
18.0  Confidentiality ....................................................................................................... 22 
A. 
Confidentiality of Study Data ............................................................................ 22 
B. 
Confidentiality of Study Specimens ................................................................... 23 
19.0  Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 23 
20.0  Withdrawal of Subjects .......................................................................................... 26 
21.0  Risks to Subjects .................................................................................................... 26 
22.0  Potential Benefits to Subjects ................................................................................ 29 
23.0  Compensation for Research-Related Injury ........................................................... 29 
24.0  Economic Burden to Subjects ................................................................................ 30 
25.0  Compensation for Participation ............................................................................. 30 
26.0  Consent Process ..................................................................................................... 31 
27.0  Waiver or Alteration of Consent Process ............................................................... 35 
28.0  Process to Document Consent ............................................................................... 35 
29.0  Multi-Site Research (Multisite/Multicenter Only) ................................................. 36 
30.0  Banking Data or Specimens for Future Use .......................................................... 36 
31.0  Drugs or Devices.................................................................................................... 37 
32.0  Humanitarian Use Devices .................................................................................... 38 
 
 
 


 
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IRB Version: JAN2016 
Template Instructions 
Sections that do not apply: 
 In several sections, the addition of checkboxes for Not Applicable have been 
added to the template as responses.   
o If an N/A checkbox is present, select the appropriate justification 
from the list.   
o If an N/A checkbox is not present, or if none of the existing 
checkboxes apply to your study, you must write in your own 
justification. 
 In addition: 
o For research where the only study procedures are records/chart 
review:  Sections 19, 20, 22, 23, 24, 25, 31, and 32 do not apply. 
o For exempt research:  Sections 31 and 32 do not apply. 
 
Studies with multiple participant groups: 
 
 If this study involves multiple participant groups (e.g. parents and children), 
provide information in applicable sections for each participant group. Clearly 
label responses when they differ.  For example: 
Response:  
Intervention Group:  
 
Control Group: 
 
Formatting: 
 Do not remove template instructions or section headings when they do not apply 
to your study. 
If you are pasting information from other documents using the “Merge Formatting” 
Paste option will maintain the formatting of the response boxes. 
Amendments: 
 When making modifications or revisions to this and other documents, use the 
Track Changes function in Microsoft Word. 
 Update the version date or number on Page 3. 
 
 


 
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IRB Version: JAN2016 
PROTOCOL TITLE: 
Include the full protocol title. 
Response: An Investigation Into The Anti-hypertensive And Potential Anti-
inflammatory Actions Of Dapagliflozin  
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response: Paresh Dandona, M.B.B.S., Ph.D., F.R.C.P, F.A.C.P, F.A.C.C 
Director, Diabetes-Endocrinology Center of Western NY 
           SUNY Distinguished Professor 
Chief of Endocrinology, SUNY at Buffalo 
1000 Youngs Road, Suite 105  
Williamsville NY 14221 
Telephone: (716) 535-1850 
Fax: (716) 639-1200 
E-mail:pdandona@kaleidahealth.org 
Co-Investigators: Husam Ghanim, PhD 
 
 
Manav Batra, MD 
 
VERSION: 
Include the version date or number. 
Response: 10/2/2018 
 
 
GRANT APPLICABILITY: 
Indicate whether this protocol is funded by a grant (e.g. NIH, foundation grant).  
For a grant with multiple aims, indicate which aims are covered by this research 
proposal. 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.     
Response:  
Funded by Astra Zeneca Inc.  
 


 
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IRB Version: JAN2016 
RESEARCH REPOSITORY: 
Indicate where the research files will be kept, including when the study has been 
closed.  The repository should include, at minimum, copies of IRB 
correspondence (approval, determination letters) as well as signed consent 
documents.  This documentation should be maintained for 3 years after the study 
has been closed.   
Response: Diabetes Endocrinology Center of WNY 
Location: 1000 Youngs Road, Suite 105, Williamsville NY 14221 
Department: Diabetes Endocrinology & Metabolism  
 
 
 
 
 
1.0 Objectives 
1.1 Describe the purpose, specific aims, or objectives of this research. 
Response: To study the effects of liraglutide (a drug used to treat type 2 
diabetes) on glucose (sugar) control over the 26 week study period when 
used in addition to insulin.  The use of Liraglutide in Type 1 Diabetes is 
investigational 
1.2 Describe the purpose, specific aims, or objectives. 
Response:   
This is a single center, prospective, randomized, placebo –controlled, parallel design and double 
blind study to investigate The Anti-hypertensive And Potential Anti-inflammatory Actions Of 
Dapagliflozin in type 2 diabetics. 
Study Aims 
Aim 1.1: To compare reactive oxygen species (ROS) generation by MNC, protein expression of 
p47phox subunit of NADPH oxidase, in MNC’s prior to and following 12 weeks of dapagliflozin or 
placebo.  
Aim 1.2: To compare intranuclear NFκB binding and the expression of JNK-1, TLR-4, SOCS-3, 
IL-1, and TNFα in MNC before and following 12 weeks of treatment with dapagliflozin or 
placebo. 
Aim 1.3: To compare plasma hs-CRP, endotoxin and IL-6 concentrations and oxidized lipids in 
plasma (TBARS) and in urine (F2-isoprostane) of obese type 2 diabetic patients prior to and 
following 12 weeks of dapagliflozin or placebo.  
Aim 1.4: To compare postprandial (after a High fat and high carbohydrates meal) changes in ROS 
generation, NFκB binding in MNC and plasma LPS prior to and following 12 weeks of 
dapagliflozin and placebo. 
Aim 2: to study the effect of single dose of dapagliflozin or placebo on oxidative stress and 
inflammatory mediators listed in Aim 1.1, 1.2 and 1.3 in MNC from obese type 2 diabetic patients. 
Aim 3.1: To evaluate effects of treatment with dapagliflozin for 12 weeks on blood pressure and 
the requirement of anti-hypertensive medication.  
Aim 3.2: To compare the in plasma concentrations of cGMP, cAMP, ANP, BNP, and a reduction 
in plasma concentrations of angiotensinogen, renin and angiotensin II before and following 12 
weeks of dapagliflozin or placebo. 


 
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1.3 State the hypotheses to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 
Response: 
 Hypothesis 1: Dapagliflozin treatment suppresses basal and meal induced oxidative and 
inflammatory stress in mononuclear cells (MNC) of patients with type 2 diabetes.  
Hypothesis 2: Dapagliflozin acutely suppresses oxidative and inflammatory stress in MNC of 
patients with type 2 diabetes 
Hypothesis 3: Treatment of patients with type 2 diabetes with dapagliflozin will reduce blood 
pressure and increase vasodilators and suppress vasoconstrictors concentrations. 
 
2.0 Scientific Endpoints 
 
2.1    Describe the scientific endpoint(s), the main result or occurrence under 
study.   
 
NOTE:  Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data.  
Include primary and secondary endpoints.  Some example endpoints are:  reduction of 
symptoms, improvement in quality of life, or survival.  Your response should not be a 
date.   
Response: The primary endpoint of the study is to detect a significant difference in the percent 
change in fasting NFκB activation (DNA binding activity) in MNC before and after dapagliflozin 
use (0 week vs. 12 weeks) as compared to placebo. Secondary endpoints include comparing 
changes in expression of p47phox, SOCS-3, IL-1, JNK-1, TLR4; and plasma concentrations of 
LPS between dapagliflozin and placebo groups. In addition, plasma concentrations of TNF-, IL-
6, IL-1, CRP, ANP, b-NP, cGMP, cAMP, angiotensinogen, renin and angiotensin II will also be 
measured at 0, 6 and 12 weeks following dapagliflozin and changes will be compared to that in 
the placebo group.    
3.0 Background 
3.1 Provide the scientific or scholarly background, rationale, and significance of 
the research based on the existing literature and how it will contribute to 
existing knowledge.  Describe any gaps in current knowledge.  Include 
relevant preliminary findings or prior research by the investigator.  
Response: Dapagliflozin is an inhibitor of SGLT-2 mediated glucose transport. This action 
inhibits the reabsorption of glucose from proximal convoluted tubules and hence induces 
glucosuria. This action has recently been utilized in the treatment of diabetes since with the 
reduction of renal threshold for glucosuria following the inhibition of SGLT-2, glucose 
concentration falls. This action is independent of insulin and β-cell function and thus, may 
potentially be of use in both type 2 and type 1 diabetes.  
Since glucose and hyperglycemia induce oxidative and inflammatory stress (1,2), it is likely that 
dapagliflozin will reduce oxidative and inflammatory stress. Since oxidative and inflammatory 
stresses are the basic mechanisms underlying atherosclerosis, a potential anti-oxidative and 
inflammatory action would be anti-atherogenic. Furthermore, dapagliflozin is also known to 


 
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IRB Version: JAN2016 
reduce blood pressure (3,4), the mechanism underlying which is not known. An anti-hypertensive 
action is also anti-atherogenic. Since dapagliflozin is currently licensed for use in type 2 diabetes 
and since this condition has a markedly increased risk of atherosclerosis and cardiovascular 
disease, it is important that the potential anti-oxidative and anti-inflammatory effects of 
dapagliflozin be investigated.  
It is also important that the mechanisms underlying the blood pressure lowering effect be 
investigated. Our recent work has shown that blood pressure lowering effect of GLP-1 receptor 
agonists, which was first described by us (5), is associated with an increase in plasma 
concentrations of known vasodilators, ANP, cGMP and cAMP; in addition, there is a reduction in 
plasma concentrations of angiotensinogen, renin and angiotensin II. Although the blood pressure 
lowering effect of SGLT-2 inhibitors is attributed to osmotic diuresis secondary to glucosuria and 
hypovolemia, it is possible that other mechanisms, as enumerated above, are involved. 
These data will provide us with novel information on the potential anti-inflammatory 
effects of dapagliflozin; in addition, they will also provide information on post prandial 
glycemia, insulinogenesis and incretin secretion. Finally, it may provide us with 
information on the mechanisms underlying the anti-hypertensive effect of this drug  
It is also important that the mechanisms underlying the blood pressure lowering effect be 
investigated. Our recent work has shown that blood pressure lowering effect of GLP-1 receptor 
agonists, which was first described by us (5), is associated with an increase in plasma 
concentrations of known vasodilators, ANP, cGMP and cAMP; in addition, there is a reduction in 
plasma concentrations of angiotensinogen, renin and angiotensin II. Although the blood pressure 
lowering effect of SGLT-2 inhibitors is attributed to osmotic diuresis secondary to glucosuria and 
hypovolemia, it is possible that other mechanisms, as enumerated above, are involved. 
 
  
 
 
3.2 Include complete citations or references.  
Response: 
 1. Mohanty, P., Hamouda, W., Garg, R., Aljada, A., Ghanim, H., and Dandona, P. 2000. Glucose 
challenge stimulates reactive oxygen species (ROS) generation by leucocytes. J Clin Endocrinol 
Metab 85:2970-2973. 
2. Aljada, A., Friedman, J., Ghanim, H., Mohanty, P., Hofmeyer, D., Chaudhuri, A., and Dandona, 
P. 2006. Glucose ingestion induces an increase in intranuclear nuclear factor kappaB, a fall in 
cellular inhibitor kappaB, and an increase in tumor necrosis factor alpha messenger RNA by 
mononuclear cells in healthy human subjects. Metabolism 55:1177-1185. 
3. Nauck, M.A., Del Prato, S., Duran-Garcia, S., Rohwedder, K., Langkilde, A.M., Sugg, J., and 
Parikh, S.J. 2014. Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide 
as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with 
metformin. Diabetes Obes Metab. 
4. Lambers Heerspink, H.J., de Zeeuw, D., Wie, L., Leslie, B., and List, J. 2013. Dapagliflozin a 
glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes 
Metab 15:853-862. 


 
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5. Viswanathan, P., Chaudhuri, A., Bhatia, R., Al-Atrash, F., Mohanty, P., and Dandona, P. 2007. 
Exenatide therapy in obese patients with type 2 diabetes mellitus treated with insulin. Endocr Pract 
13:444-450. 
6. Chaudhuri, A., Ghanim, H., Vora, M., Sia, C.L., Korzeniewski, K., Dhindsa, S., Makdissi, A., 
and Dandona, P. 2012. Exenatide exerts a potent antiinflammatory effect. J Clin Endocrinol Metab 
97:198-207. 
7. Dandona, P., Aljada, A., Mohanty, P., Ghanim, H., Hamouda, W., Assian, E., and Ahmad, S. 
2001. Insulin inhibits intranuclear nuclear factor kappaB and stimulates IkappaB in mononuclear 
cells in obese subjects: evidence for an anti-inflammatory effect? J Clin Endocrinol Metab 
86:3257-3265. 
8. Ghanim, H., Garg, R., Aljada, A., Mohanty, P., Kumbkarni, Y., Assian, E., Hamouda, W., and 
Dandona, P. 2001. Suppression of nuclear factor-kappaB and stimulation of inhibitor kappaB by 
troglitazone: evidence for an anti-inflammatory effect and a potential antiatherosclerotic effect in 
the obese. J Clin Endocrinol Metab 86:1306-1312. 
9. Makdissi, A., Ghanim, H., Vora, M., Green, K., Abuaysheh, S., Chaudhuri, A., Dhindsa, S., 
and Dandona, P. 2012. Sitagliptin exerts an antinflammatory action. J Clin Endocrinol Metab 
97:3333-3341. 
 
 
4.0 Study Design 
4.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response: This is a single center, prospective, randomized, placebo –controlled, parallel design 
and double blind study. The study will be conducted at the Diabetes – Endocrinology Center of 
Western New York under the direction of Dr. Paresh Dandona, M.D. 
Two groups of 26 patients each (total 52 patients) with type 2 diabetes on oral agents will be 
included in the study. One group will be randomized to dapagliflozin (a dose of 5 mg daily will 
be titrated to 10 mg daily during the first week) while the other will be placebo. The patients will 
be treated for 12 weeks. Randomization will take in consideration even distribution of patients in 
regards to background medications (statins, ACE inhibitors, TZDs and ARBs). Only half the 
patients (equal numbers in both groups) will be tested for the secondary endpoints related to 
postprandial and single dose induced changes.   
 
5.0 Local Number of Subjects 
5.1 Indicate the total number of subjects that will be enrolled or records that will 
be reviewed locally. 
Response: 52 
5.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response: 65-75. All screened and qualified patients will be enrolled and randomized 
up to 52 enrolled patients. 


 
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5.3 Justify the feasibility of recruiting the proposed number of eligible subjects 
within the anticipated recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit? 
Response: The Diabetes and Endocrinology Center of WNY is the largest Diabetes 
center in the WNY area, seeing between 60 and 100 type 2 diabetic patients every month. 
Therefore, majority of recruited patients are our clinic patients. We do recruit a few 
patients through advertisement and researchmatch.org. These sources will suffice to 
recruit the needed number to subjects. 
6.0 Inclusion and Exclusion Criteria 
6.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response:  
 
Age 20-80 years inclusive. 
 
Type 2 diabetes 
 
BMI ≥30 kg/m2 
 
Subjects on statins, ACE inhibitors, ARBs, diuretics, DPP-IV inhibitors, thiazolidenediones and 
antioxidants will be allowed as long as they are on stable doses (same dose for last 3 months) of 
these compounds and the dosage in not changed during the course of study. Patients will be evenly 
distributed between the 2 groups based on statins, ARBs, TZDs and ACE inhibitors use.  
 
HbA1c ≤ 8.0% 
6.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:   
 
Use of GLP-1 agonists or SGLT-2 inhibitors therapy in the last 3 months. 
 
Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and hypertriglyceridemia. 
 
Coronary event or procedure (myocardial infarction, unstable angina, coronary artery 
bypass, surgery or coronary angioplasty) in the previous 3 months. 
 
Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver function 
defined as: 
1.  aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine 
aminotransferase (ALT) >3x ULN 
2. Total bilirubin >2.0 mg/dL (34.2 µmol/L) 
3. Positive serologic evidence of current infectious liver disease including Hepatitis B viral 
antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody 
 
 (liver function tests more than 3 times the upper limit of normal) 
 
Renal impairment (serum eGFR <60 ml/min) 
 
Any other life-threatening, non-cardiac disease 
 
Uncontrolled hypertension (BP > 160/100 mm of Hg) 
 
Congestive Heart Failure class III or IV. 
 
Use of an investigational agent or therapeutic regimen within 30 days of study 
 
Participation in any other concurrent clinical trial  
 
pregnant or breastfeeding patients 


 
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 
Volume  depleted  patients.  Patients  at  risk  for  volume  depletion  due  to  co‐existing 
conditions. 
 Those with a history of bladder cancer, Diabetic Ketoacidosis (DKA) 
 
6.3 Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.   
 
NOTE:  Members of special populations may not be targeted for enrollment in 
your study unless you indicate this in your inclusion criteria. 
Response:  None of the below populations will be enrolled 
☐ 
Adults unable to consent 
☐ 
Individuals who are not yet adults (infants, children, teenagers) 
☐ 
Pregnant women 
☐ 
Prisoners 
6.4 Indicate whether you will include non-English speaking individuals in your 
study.  Provide justification if you will exclude non-English speaking 
individuals.  
In order to meet one of the primary ethical principles of equitable selection 
of subjects, non-English speaking individuals may not be routinely excluded 
from research as a matter of convenience. 
In cases where the research is of therapeutic intent or is designed to 
investigate areas that would necessarily require certain populations who may 
not speak English, the researcher is required to make efforts to recruit and 
include non-English speaking individuals.  However, there are studies in 
which it would be reasonable to limit subjects to those who speak English.  
Some examples include pilot studies, small unfunded studies with validated 
instruments not available in other languages, studies with numerous 
questionnaires, and some non-therapeutic studies which offer no direct 
benefit. 
Response: We have no non-English speaking patients in this population.  
We have patients that English is a second language, but they are able to 
read, write and understand it.  This population is less than 10% of the total 
population. 
7.0 Vulnerable Populations 
If the research involves special populations that are considered vulnerable, 
describe the safeguards included to protect their rights and welfare.   
NOTE: You should refer to the appropriate checklists, referenced below, to ensure you 
have provided adequate detail regarding safeguards and protections. You do not, 
however, need to provide these checklists to the IRB. 
7.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 


 
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Response: We will not be using subjects from vulnerable populations 
☒ 
N/A:  This research does not involve pregnant women. 
7.2 For research that involves neonates of uncertain viability or non-viable 
neonates, safeguards include: 
NOTE CHECKLISTS: Non-Viable Neonates (HRP-413), or Neonates of Uncertain 
Viability (HRP-414) 
Response:  
☒ 
N/A:  This research does not involve non-viable neonates or neonates of 
uncertain viability. 
7.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
☒ 
N/A:  This research does not involve prisoners. 
7.4 For research that involves persons who have not attained the legal age for 
consent to treatments or procedures involved in the research 
(“children”), safeguards include:   
NOTE CHECKLIST: Children (HRP-416) 
Response:  
☒ 
N/A:  This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures (“children”). 
7.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
☒ 
N/A:  This research does not involve cognitively impaired adults. 
7.6 Consider if other specifically targeted populations such as students, 
employees of a specific firm, or educationally or economically 
disadvantaged persons are vulnerable.  Provide information regarding 
their safeguards and protections, including safeguards to eliminate 
coercion or undue influence. 
Response: No specific populations or vulnerable groups will be targeted. All 
subjects enrolled in this study will be of legal adult consenting age with the ability 
to speak, read and interrupt the English language. Patients will have the ability to 
speak with the research team regarding any questions or concern they have before 
signing the consent. Patients are made aware that this study is voluntary and they 
are able to stop participating at any time they feel uncomfortable. Patients are not 
be pressured into participating and their clinic standard of care will remain the 
same if they participate or choose not to participate.  
8.0 Eligibility Screening  
8.1 
Describe screening procedures for determining subjects’ eligibility.  
Screening refers to determining if prospective participants meet inclusion and 
exclusion criteria.  


 
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Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire).  
Response: :  
Prospective participants will be asked to read and understand the consent and any 
questions they may have regarding the protocol will be answered. If the subject wants 
to participate in the study, they will be asked to sign the informed consent form. The 
subject’s medical history and current medications will be obtained as well as their 
blood pressure and vitals. A physical examination will also be done.  Fasting labs 
before 10:00am include; Pregnancy test, urine and baseline blood draw to measure CBC, 
CMP and HbA1c 
All qualifying patients will be randomized to drug or placebo groups according a randomization 
chart prepared by Microsoft Excel software on a 1:1 ratio.  All patients will start receiving 
study medication at visit 1B.  24 hr urine collection container will be provided and patients will 
be instructed to start collecting urine 24 hours prior to visit 1B if qualified. 
☐ 
N/A:  There is no screening as part of this protocol. 
9.0 Recruitment Methods 
☐ 
N/A:  This is a records review only, and subjects will not be 
recruited.  NOTE:  If you select this option, please make sure that 
all records review procedures and inclusion/exclusion screening 
are adequately described in other sections. 
9.1 
Describe when, where, and how potential subjects will be recruited.  
NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study.  Include specific methods you will use (e.g. 
searching charts for specific ICD code numbers, Research Participant Groups, 
posted advertisements, etc.). 
Response: Participants will be identified by prescreening clinical charts, patient 
doctor interaction at the time of their visits, flyers advertisements and 
researchmatch.org. Diabetes Endocrinology Center of WNY Locations include: 
1. 1020 Youngs Road, Williamsville NY 14221 
2. 705 Maple Road, Williamsville NY 14221 
3. 462 Grider Street, Buffalo NY 14215  
4. 1000 Youngs Road, Suite 105, Williamville NY 14221 
The study clinical team will evaluate their clinic patients for possible participation 
in this study according to the inclusion and exclusion criteria at the Diabetes and 
Endocrinology Center of WNY. Patients that may qualify for the study are 
referred to the research team for further eligibility evolution. Patients meeting the 
inclusion and exclusion criteria based on preliminary phone evaluation will be 
invited to participate in the study. 
9.2 Describe how you will protect the privacy interests of prospective subjects 
during the recruitment process.   
NOTE:  Privacy refers to an individual’s right to control access to him or herself.