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Research

Tulane Diabetes Research Program


Franck Mauvais-Jarvais, MD, PhD

The mission of the Tulane Diabetes Research Program is to provide a collaborative research community and infrastructure to Tulane research investigators studying the molecular bases and therapeutic avenues for diabetes mellitus, obesity and their complications.  

Franck Mauvais-Jarvis, MD, PhD, Director of the Tulane Diabetes Research Program, Price-Goldsmith Professor of Nutrition


lab

A variety of research resources are available in the Section of Endocrinology. A list of current studies is found below. These research projects and others through the Clinical Trials Cooperative provide numerous opportunities for research and scholarly publication, and are an integral part of the Endocrinology department. Publications relating to this research are found on our publications page. For more publications, please reference specific faculty or fellow pages.


Current Studies



MEDIAN Study


Protocol #M-003 – “A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to assess the safety and nutritional benefits of Metanx® in Subjects with Diabetic Peripheral Neuropathy” (MEDIAN Study)


PI: Tina Thethi, MD


PROTOCOL SUMMARY:

The purpose of this research study is to determine the benefits of Metanx in diabetic peripheral neuropathy (DPN), blood flow, how the nerves are working, and how DPN affects a subject’s lifestyle.  This research study will compare Metanx® to placebo.

 

The study product, Metanx, is classified as an orally administered medical food.  A medical food is intended to provide nutrients that may help manage a disease and are missing from a normal diet.  Medical foods such as the study product are not approved by the U.S. Food and Drug Administration (FDA) but must meet FDA standards for food safety and manufacturing.  Metanx contains a combination of L-methylfolate calcium, methylcobalamin, and pyridoxal-5’-phosphate, and is currently available in the United States as a prescription medical food under a doctor’s supervision.  A previous research study of Metanx in subjects with type 2 diabetes and diabetic peripheral neuropathy (DPN) has shown the study product to be safe and well-tolerated, and may improve symptoms due to DPN and overall quality of life.


Study Status: Recruiting study subjects




SORELLA 2 Study


Protocol #EFC13403 - "Six-month, Randomized, Open-label, Parallel-group Comparison of the Insulin Analog SAR342434 to Humalog in Adult Patients With Type 2 Diabetes Mellitus also Using Insulin Glargine" (SORELLA 2)


PI: Tina Thethi, MD


PROTOCOL SUMMARY:

The purpose of this research study is gather data in subjects diagnosed with diabetes.  The purpose is to compare the performance of glycated albumin to other traditional markers of glycemic control in diabetic subjects.


Currently there are multiple ways to measure blood sugar including Blood Glucose Tests and Glycated Hemoglobin (HbA1c) Tests.  The investigational device being studied is the Lucica Glycated Albumin-L assay and is intended to be used for measuring glycated albumin.  The measurement of glycated albumin by using the Lucica Glycated Albumin-L assay may reflect changes in the average blood glucose levels faster than HbA1c testing.


Type 1 and Type 2 diabetics 18+ are eligible to participate.


Study Status: Recruiting study subjects



DURATION 7 Study


Protocol #D5553C00002 – “A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine with or without Metformin”


PI: Tina Thethi, MD


PROTOCOL SUMMARY:

The purpose of this research study is to see if an investigational drug called exenatide, taken once weekly by injection, is effective in treating type 2 diabetes in people whose diabetes is not well-controlled by either insulin glargine alone or insulin glargine taken with metformin or metformin plus a sulfonylurea.  (Metformin and sulfonylureas are drugs used to treat type 2 diabetes.)  This study will also measure levels of the study medication in the blood and see how the body accepts the study medication.


Study Status: Recruiting study subjects



BZA/CE Study


Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism


PI: Franck Mauvais-Jarvis, MD, PhD


PROTOCOL SUMMARY:

The purpose of this research study is to determine if Bazedoxifene/Conjugated Estrogens (BZA/CE) [brand name DUAVEE], a new prescription medicine that contains a mixture of
estrogen and bazedoxifene) can reduce obesity and associated pre-diabetes in obese postmenopausal women during a short study of 3 months.


Study Status: Recruiting study subjects



Gilead Study


Protocol #GS-US-223-1015 – “A Phase 2 Double-Blind, Placebo-
Controlled, Dose-Ranging Study Evaluating the Efficacy, Safety and Tolerability of GS 4997 in Subjects with Diabetic Kidney Disease”


PI: Vivian A. Fonseca, MD


PROTOCOL SUMMARY:

The purpose of this research study is to explore whether GS-4997 slows or stops progression of kidney disease in patients with DKD.


Study Status: Recruiting study subjects



CARMELINA Study


Protocol #1218.22 – “A multicenter, international, randomized, parallel group, double blind, placebo-controlled CArdiovascular Safety & Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk” – CARMELINA


PI: Tina Thethi, MD


PROTOCOL SUMMARY:

The purpose of this research study is to investigate the impact of treatment with a drug called linagliptin on the long–term occurrence of selected complications of cardiovascular disease (for example  stroke or heart attack), as compared to the placebo, in patients with type 2 diabetes mellitus already receiving the standard of care treatment. In addition, the study will investigate the impact of treatment with linagliptin on kidney disease in patients with type 2 diabetes mellitus.


Study Status: Recruiting study subjects



ABPM Study

To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure:  A Pilot Study


PI: Tina Thethi, MD


PROTOCOL SUMMARY:

A research study evaluating the effects of a drug: liraglutide (Victoza) on blood pressure. Liraglutide is a drug approved by FDA (Food and Drug Administration) to treat Type 2 Diabetes Mellitus. It is given under the skin daily.


Blood pressure will be monitored using the 24 hour Ambulatory Blood Pressure monitor: a device that monitors  blood pressure while continuing normal activity.  We will also measure the endothelial function using a machine: ENDOPAT.  This is a non-invasive diagnostic test which is done in the doctor’s office. The test usually takes about 15 minutes. It is not painful. It generates an EndoScore which indicates the current state of the endothelial health.


Study Status: Recruiting study subjects



Intarcia 107 Study

Protocol #ITCA 650-CLP-107 – “A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 Diabetes”


PI: Tina Thethi, MD


PROTOCOL SUMMARY:

The purpose of this research study is to evaluate the number and type of events associated with body systems related to the heart and blood vessels (cardiovascular system) and to test the safety and effectiveness of long-term treatment with ITCA 650 with diet and exercise and Standard of Care medication(s) in people with diabetes.


Study Status: Study closed to enrollment



SUSTAIN Study

Protocol #NN9535-3744 – SUSTAIN™ 6 – Long-term Outcomes - “A long-term, randomized, double-blind, placebo-controlled, multinational, multi-centre trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes”


PI: Tina Thethi, MD


PROTOCOL SUMMARY:

The purpose of this research study is to investigate whether subjects with type 2 diabetes with increased risk of cardiovascular events can safely and effectively add semaglutide to their current treatment. In addition, the trial will also test the long-term effects of semaglutide on heart and blood vessels, as well as on regulation of blood sugar, body weight, quality of life, and other specific parameters.


Study Status: Study closed to enrollment



EndoBarrier Study

Protocol #09-1 – “A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier® Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents”


PI: Vivian A. Fonseca, MD


PROTOCOL SUMMARY:

The purpose of this research study is to evaluate the safety and initial efficacy (the effectiveness) of the EndoBarrier Gastrointestinal Liner System in uncontrolled Type 2 diabetic subjects who are also obese.


Study website: www.endobarriertrial.com


Study Status: Study enrollment temporarily on hold



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