AM Research

Current Clinical Research Studies at AM Diabetes:


AM Diabetes and Endocrinology Center is a regional leader in Diabetes Research, specializing in the study and investigation of cutting-edge treatments, and is committed to finding better ways to improve the health and welfare of adults and children with Type 1 and Type 2 Diabetes.

Currently, we are involved in research studies for people with Type 1 and Type 2 diabetes. All procedures/exams
directly related to study participation (such as office visits, lab work, physical exams, diagnostic procedures,
doctor time and nurse time) are offered free of charge. In addition, the study medication in a clinical trial is
provided free of charge, and usually there is compensation for time and travel.

We are frequently starting new studies, so if you are a diabetic and are interested in possible
participation or learning more about our current studies… please call AM Diabetes at
901.384.0065 and ask to speak to the research staff, or send us an email… This email address is being protected from spambots. You need JavaScript enabled to view it..

Medical Research is crucial to understanding diseases and developing new ways to prevent, detect, and/or
treat health problems. Our research was established in 2002. Most of our clinical trials focus on new ways of treating DIABETES and the complications of DIABETES.

What is a Clinical Trial?
Clinical trial. Clinical study. Research study. They all mean about the same thing - a closely monitored scientific
study to evaluate how a new or investigational medication or treatment works in people. They determine how
effective a medication or treatment is in combating a disease or medical condition.
The discovery of new treatments is impossible without the support of patients participating in clinical studies.
We carefully match individual patient's needs with each study's criteria to determine eligibility. Participants in
the studies have access to cutting-edge care that is not available in many other doctors’ offices or medical
centers.

Why Are Clinical Trials Important?
Medical treatments have come a long way in the last 30 years. Today, many more patients are living healthier
lives with medical conditions or disease; and many more are surviving serious illnesses who might not have
survived years ago. This is due to improvements in medications, therapies, and diagnostic tests. These
improvements have come about through research. However, there still are many questions to be answered about
treatments, and room for improvement of current medications. These are the reasons why AM Research is an important division of AM Diabetes Center.

Why would you be Interested in Clinical Trials?
Usually patients participate in clinical trials because they hope to benefit themselves, and because they want to
contribute to a research effort that helps others. A patient's well-being is paramount in a clinical trial. If you are
involved in a clinical trial, you will be closely monitored to see how you are responding to treatment and to
determine your overall well-being. Whether to participate in a study, or whether to continue to participate in a
study is always up to you… you may withdraw from a study at any time.

Are Clinical Trials Safe?
Patient safety is extremely important to us at AM Diabetes. Before a clinical trial begins, the treatment must
show that it has potential benefit. It also must meet rigorous government standards (i.e. FDA) and scientific
requirements for safety, and have acceptable side effects. Physicians and research nurses follow strict rules
when conducting clinical trials. These rules protect the interests of the patient and remove any bias from the
study. In addition, no patients may be enrolled in a clinical trial until the trial has been approved by an
Institutional Review Board (IRB). The board is responsible for evaluating proposed trials for ethical research
practices, patient safety and patients' rights.

How can I know Exactly what is Involved in a Clinical Trial?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to
participate. It is also a continuing process throughout the study to provide information for participants. To help
you decide whether or not to participate, you will be given an informed consent document that includes details
about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential
benefits are also explained in this document. After reading it, you will be encouraged to ask questions so that
you have a thorough understanding. You then decide whether or not to sign the document. Informed consent is
not a contract, and the participant may withdraw from the trial at any time.

How much does it Cost to be in a Clinical Trial?
There is no cost to you to participate. All procedures/exams directly related to study participation (such as
office visits, lab work, physical exams, diagnostic procedures, doctor time and nurse time) are offered free of
charge. In addition, the study medication in a clinical trial is provided free of charge, and usually there is
compensation for time and travel.

How can you Participate in a Clinical Research Trial?
You may choose to participate in a clinical research trial, but the study doctor will determine if you are eligible.
You must meet certain study-specific criteria to participate. Each study includes patients who have the same or
very similar health profiles based on criteria related to: medical history, medication history, and current medical
status.
You do not have to be a patient at the Center to participate in one of our studies. You would see us for your
study visits, and continue to see your own doctor for your routine care. We will gladly inform your current
doctor of your participation in the study. At your request, we will also send your study lab and test results to his
office to include in your medical record.

If you are a diabetic and interested in possible participation or learning more
about our current studies, please call…
AM Diabetes at 901.384.0065 and ask to speak to the study nurse, or
send us an email… This email address is being protected from spambots. You need JavaScript enabled to view it.

Information for Sponsors and Clinical Research Organizations:

Dr. Latif’s Clinical Trial Experience as Principal Investigator:

2002 Evaluation of anti-hypertensive medication in patients with Diabetes and
Renal Insufficiency
2002 Evaluation of 2 different Anti-Hypertensive medications in patients with Diabetes.
2003 Evaluating efficacy of 70/30 Insulin in patients with Diabetes.
2004 Evaluation of DPP-IV Inhibitors in the treatment of Diabetes.
2005 Evaluation of DPP4 Inhibitors with add on therapy in the treatment of Diabetes.
2005 Impact of Nutrition counseling with Insulin therapy in Insulin-Naive Diabetics.
2005 Evaluation of Insulin Inhalation Powder in patients with COPD and Asthma.
2005 Evaluation of an investigational product for Diabetes and Chronic Renal Failure.
2006 Evaluation of Insulin Inhalation Powder in Patients with Type I Diabetes
2006 Evaluation of DPP4 Inhibitor in drug-naïve Type II Diabetics.
2007 Evaluation of inhaled insulin in Patients with Type II Diabetes
2007 Evaluation of DPP4 Inhibitor in drug-naïve Type II Diabetics
2008 Evaluation of [S,S]-Reboxetine in Patients with Chronic Painful Diabetic
Peripheral Neuropathy
2008 Evaluation of Insulin Inhalation Powder vs Lispro in Patients with type II Diabetes
2008-2010 Evaluation of vildagliptin versus sitagliptin in patients with Type II Diabetes and
Severe Renal Insufficiency.
2008-2010 Evaluation of Insulin Inhalation Powder in combination with Lantus vs
Humalog in combination with Lantus in Patients with Type 1 Diabetes.
2008-2010 To evaluate the efficacy and Long-Term safety of vildagliptin modified release (MR) as
monotherapy in patients with Type 2 Diabetes.
2008-2011 Safety and efficacy of PROCHYMAL (ex vivo cultured adult human mesenchymal stem
cells) for the treatment of recently diagnosed type 1 diabetes mellitus (T1DM).
2009-2011 Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to
Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome.
2010 Evaluate Efficacy and Safety of a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal
Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus.
2010-2011 Evaluate Efficacy and Safety of Pregabalin in the Treatment of Patients with Inadequately
Treated Painful Diabetic Peripheral Neuropathy.
2010-2013 Determine Liraglutide Effects on Cardiovascular Events.
2010-2013 Evaluate the Clinical Efficacy and Safety of DIAPEP277 in Newly Diagnosed Type 1
Diabetic Subjects.
2011-2013 Cardiovascular outcomes during treatment with Lixisenatide in Type 2 Diabetics after an
Acute Coronary Syndrome.
2013Evaluation
of Metabolic Outcomes and Safety of Hylenex recombinant (hyaluronidase human
injection) used as a Preadministration Infusion Site Treatment in Subjects with Type 1 Diabetes
(T1DM) Using Continuous Subcutaneous Insulin Infusion (CSII)