Welcome
EndoTrials is San Diego's creative, collaborative, and open-minded Clinical Research Center that is founded, managed, and run by true MD-PhD Physician-Scientists.
EndoTrials
Clinical Research Center
8851 Center Drive Suite 404
La Mesa, CA 91942
Phone: 619-463-1293
Fax: 619-463-8230
Email: info@endotrials.org
Web: www.endotrials.org
About Us
EndoTrials is San Diego's new Clinical Research Center that is founded, managed, and run by true MD-PhD Physician-Scientists.Clinical research studies are crucial for the development of new therapies. We are accomplished basic and clinical researchers with vast experience in the field of endocrinology and diabetes. We are always interested in being at the cutting edge of science and technology and to help move our field forward - for the benefit of our patients.The mission of our newly founded EndoTrials Clinical Research Center is to help discover, apply and translate science about endocrine disease, diabetes, and their complications, to improve health and wellness.EndoTrials continues the clinical and research legacy of “Diabetes and Endocrine Associates" - Daniel Einhorn MD and Raymond Fink MD, a local and regional hallmark research practice that has been operating in the same locations since 1991.What sets us apart?
EndoTrials builds upon decades of know-how in clinical care and research, but what sets us apart is the operational nimbleness needed today. We are problem-solvers and creative thinkers, committed to the highest quality standards. “EndoTrials” Clinical Research Center is in a unique position relative to comparable sites contending for clinical studies, and here are some factors setting this site apart:Staff Qualifications
Both clinicians at the site, Darius Schneider MD/PhD (the site owner) and Mba Uzoma Mba MD/PhD, are double board-certified internists and endocrinologists who have trained at prestigious academic centers both in the USA and in Europe. In addition, both are accomplished Physician-Scientists with PhD degrees in fields related to endocrine research, hence combining exceptional clinical skills and scientific expertise. Sara Turner-Cooper PA-C, PhD, the research coordinator, is a certified Physician Assistant with a PhD degree completed in molecular biology prior to devoting her career to the care for patients with endocrine conditions and diabetes. In addition, the Director for Research, Robert Lipetz DO, has a long and successful history of working in the research industry having completed more than 500 clinical trials as a primary investigator, with at least half of these studies done in the field of endocrinology and predominantly Type 2 Diabetes.Facilities and Equipment
Our facility in La Mesa has ample space available for clinical trials, with well-equipped examination rooms, adequate secure drug, device, and document storage space, state-of-the-art equipment needed for clinical studies (research grade refrigerators and freezers with 24/7 monitoring, centrifuges, EKG machine, lung spirometer, DEXA bone densitometer, ultrasound, retinal camera), as well as professional grade office machines and devices and high-speed fiber internet and WiFi access points.Site Profile
The facility in La Mesa is an integral part of a large endocrine practice that has been functioning in the very same location for the past 30 years and is very well known and respected in the community, both by referring offices as well as patients. Our physicians are busy clinicians committed to providing the highest level of endocrine care to many thousands of patients. The site does not have its own Institutional Review Board (IRB) providing added flexibility regarding timelines.Population Profile and Access
The site has a patient population exceeding 20,000 with a highly diverse mix of ethnic and racial subgroups. The site’s catchment area extends as far East as El Centro and Imperial Valley and includes a well-balanced mix of White, Black, Asian, and American Indian populations. In addition, La Mesa, and the adjacent El Cajon, are home to a vast Iraqi and Chaldean population (largest in the US).Being directly connected to a large endocrinology practice with offices in La Mesa, La Jolla, and Poway, as well as holding strong collaboration ties with San Diego’s largest Private Practice Physician Groups, Sharp Community Medical Group, with a network of over 800 primary care and specialty physicians working in 350 locations in San Diego County, gives “EndoTrial” access to a very large and diverse pool of potential clinical study participants.Location
“EndoTrials” is located on the Grossmont Medical Campus, a hallmark of La Mesa which is very well connected to local freeways (I8, I125) as well as public transportation (several bus lines as well as the San Diego Trolley have stops in walking distance) making the site very easily accessible to patients and participants who rely on public transportation. San Diego International Airport is 15 automobile minutes away and can be easily reached with the San Diego Trolley. Most site patients, and potentially eligible research study participants, live and work in immediate proximity to the site.Vision and Goals
Our goal from the first consideration was to establish a highly regarded, Physician-Scientist managed site for clinical research pertinent to the field of endocrinology and diabetes, that would perform at the highest level starting from the very first study. To ensure this, we have sought extensive training for our staff and primary investigators. Work practice guidelines and standard operating procedures for “EndoTrials” were developed along with site-specific forms to be used while conducting clinical research studies. All documents including GCP training and IATA, EDP, IMP certifications, are available for review upon request.We are very excited to become a valuable site with study participants that will be appropriately managed as part of clinical trials at the highest levels possible. We are looking forward to discussing any questions that potential sponsors or study participants may have.
Our Team
Scientific MindsEndoTrials is led and managed by true Physician-Scientists who have devoted their practice to helping people with endocrine diseases and to the advancement of the fields of endocrinology and diabetes.At EndoTrials, we are combining our passion for scientific rigor honed during decades of cutting-edge research experience with our love for patient care and our compassion.At EndoTrials, we are problem-solvers and creative thinkers, committed to opening the doors between sparkling ideas and proven and safe therapies.At EndoTrials, we navigate obstacles with unmatched competence, agility, and the ease of a smile.
Darius A. Schneider MD, PhD
President, Research InvestigatorDr. Schneider trained in Internal Medicine, Endocrinology, and Metabolism at the Universities of Heidelberg, Germany, the University of California San Diego, and the University of Washington, Seattle and gained extensive experience in managing all subtypes of diabetes, thyroid disease, parathyroid disease, Cushing's syndrome and disease, pituitary tumors, prolactinomas and fertility, pheochromocytoma and paragangliomas, endocrine tumor syndromes, hypertension, lipids, and bone.Dr. Schneider is an accomplished clinician who trained in Internal Medicine, Endocrinology, and Metabolism at the Universities of Heidelberg, Germany, the University of California San Diego, and the University of Washington, Seattle as well as an accomplished basic and clinical researcher. He completed a Ph.D. with work in pancreatic islet transplantation and was subsequently awarded a Fulbright fellowship to undertake research in the field of diabetes and immunology in the lab of Matthias von Herrath at the prestigious "La Jolla Institute for Allergy and Immunology". Later, Dr. Schneider worked with William "Bill" Hagopian at the "Pacific Northwest Research Institute" in Seattle investigating risk scores for the prediction and correct diagnosis of diabetes subtypes as well as environmental factors in the development of Type 1 Diabetes (TEDDY study).Dr. Schneider is a co-investigator on several diabetes research studies; his extensive research background in endocrinology and immunology gives Dr. Schneider a unique perspective and underpins his pursuit of improved understanding of and better treatments for endocrine and related diseases.
Mba Uzoma Mba MD, PhD
Research InvestigatorEndoTrials is led and managed by true Physician-Scientists who have devoted their practice to helping people with endocrine diseases and to the advancement of the fields of endocrinology and diabetes.At EndoTrials, we are combining our passion for scientific rigor honed during decades of cutting-edge research experience with our love for patient care and our compassion.At EndoTrials, we are problem-solvers and creative thinkers, committed to opening the doors between sparkling ideas and proven and safe therapies.At EndoTrials, we navigate obstacles with unmatched competence, agility, and the ease of a smile.
Robert Lipetz DO
Research InvestigatorRobert "Bob" Lipetz is an incredibly accomplished clinical researcher with a long and successful history of working in the research industry. Dr. Lipetz has completed more than 500 clinical trials as a primary investigator, at least half of these studies in the field of endocrinology and predominantly Type 2 Diabetes. He brings unmatched expertise to the team.
Sara Turner Cooper PhD, PA-C
Research Coordinator
Current Studies
Currently Recruiting
REIMAGINE-4 (Novo Nordisk)
ClinicalTrials.gov ID: NCT06221969A research study to see how much CagriSema ® lowers blood sugar and body weight compared to Tirzepatide (Mounjaro®) in adults with Type 2 Diabetes treated with Metformin with or without an SGLT2 inhibitor. Cagrisema is a combination of the glucagon like peptide 1 agonist (GLP1a) Semaglutide (Ozempic ®) with a dual receptor agonist at the amylin and the calcitonin receptor, with very high efficacy in the treatment of obesity, and Type 2 Diabetes.
As a comparison: Semaglutide (Ozempic®) is a single receptor agonist (GLP1a), Tirzepatide (Mounjaro ®) is a dual receptor agonist (GIP, GLP1), and CagriSema is a triple hormone receptor agonist.
This is the first head-to-head comparison of Novo Nordisk’s Cagrisema with Lilly’s Mounjaro!Key inclusion criteria
• Age 18 years or above at the time of signing the informed consent
• Diagnosed with type 2 diabetes ≥ 180 days before screening
• Stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose:
o metformin with or without an
o SGLT2 inhibitor
• HbA1c 7.0-10.5% as determined at screening
• BMI ≥ 30 kg/m2 at screeningKey exclusion criteria
• Woman who is pregnant, or intends to become pregnant, or who is breast-feeding
• Renal impairment with estimated Glomerular Filtration Rate < 30 ml/min/1.73 m2
• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
TRANSCEND-T2D-3 (Lilly)
ClinicalTrials.gov ID: NCT06297603The purpose of this study is to investigate the efficacy and safety of Retatrutide 4 mg, 9 mg, or 12 mg administered once weekly for 52 weeks compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor.
Retratutide is a novel triple incretin hormone agonist: gastric inhibitory polypeptide (GIP), glucagon-like peptide-1 (GLP-1) and glucagon receptor, with very high efficacy in the treatment of obesity, Type 2 Diabetes and NAFLD.
As a comparison: Semaglutide (Ozempic®) is a single receptor agonist (GLP1a), Tirzepatide (Mounjaro ®) is a dual receptor agonist (GOPa, GLP1a).Key Inclusion Criteria:
• Age ≥ 18 years at time of consent
• Type 2 Diabetes (T2D)
• HbA1c ≥7.0% to ≤10.5%
• moderate or severe renal impairment as defined below:
o estimated glomerular filtration rate (eGFR) 15 to <60 mL/min/1.73 m
o if using metformin: eGFR 45 to <60 mL/min/1.73 m²
o if using SGLT2 inhibitor: Have an eGFR greater than the threshold criteria for discontinuing or adjusting the dose per local label
• Have a Body Mass Index (BMI) ≥23.0 kilograms per meter squared (kg/m2)
• Have been on the following stable diabetes treatment during 90 days prior to screening
o basal insulin (≥20 International Units (IU)/day) with or without
o metformin and/or SGLT2 inhibitorKey Exclusion Criteria:
• Type 1 Diabetes (T1D)
• History of severe hypoglycemia or hypoglycemia unawareness within the last 6 months
• Receiving or planning to receive treatment for diabetic retinopathy and/or diabetic macular edema
• Unstable or rapidly progressing renal disease
• Prior or planned surgical treatment for obesity (bariatric surgery)
• Congestive heart Failure NYHA Functional Classification III or IV
• Acute myocardial infarction, stroke, or hospitalization for congestive heart failure within 90 days prior to screening
• The study will last about 14 months and may include up to 22 visits. Generous visit stipends are provided.
EndoTrials
Clinical Research Center
8851 Center Drive Suite 404
La Mesa, CA 91942
Phone: 619-463-1293
Fax: 619-463-8230
Email: info@endotrials.org
Web: www.endotrials.org