Our experience

The department of clinical pharmacology is a part of SI “Institute endocrinology and metabolism”. We conduct pharmaceutical clinical trials for a wide range of endocrine diseases although the primary focus has been on diabetes research on type 1 and 2 patients. We have been conducting endocrine-related clinical research for close to 20 years and have participated in over 50 trials focusing on the development of new drugs. Our research has resulted in many important drugs coming to market for the benefit of our patient’s health. Our dedicated staff of clinical research coordinators, with over 20 years of combined experience in the execution of these trials, are committed to providing the best environment for patients. People who participate in clinical research receive the benefits of free care of our dedicated physicians to advance their health and the health of all patients with endocrine disorders.

Dr. Zinych has over 15 years cumulative research experience and have worked together as a research team for more than 10 years. She worked last 5 years as Principal Investigator.  In addition to their extensive experience, all of our providers (principal investigator and sub-investigators) are on site Monday – Friday and are available to address any questions or concerns research participants have at any time. The PI and all Sub-Investigator  are  familiar with every single person enrolled, and we hold weekly meetings with the entire team to discuss all study participants, protocol updates, or any other applicable information regarding protocol training and patient safety.

The majority of our study participants are longtime patients of our doctors, and because we have extensive medical histories available, we are able to minimize screen failures. Knowing our patients well also helps ensure that participants will complete the study, as all study participants receive comprehensive care from their regular doctor.

Clinical trials are conducted by department of clinical pharmacology for a variety of conditions, which may include the following:

  • Diabetes
  • Investigational and pharmacological therapies for type 1 and type 2 diabetes
  • Devices and delivery systems for managing diabetes
  • Diabetes prevention and management
  • Continuous glucose monitoring systems
  • Diabetes in high risk populations
  • Standards of care
  • Epidemiology of diabetes
  • Phase II – IV clinical trials
  • Cardiovascular disease, hypertension and other diabetes co-morbidities
  • Obesity/Metabolic Syndrome
  • Lipid metabolism
  • Vascular compliance and reactivity
  • Nutrition and feeding habits
  • Obesity treatment and management
  • Body composition
  • Thyroid Disorders

List of study

NCT01463397
Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain
Phase II: Neuropathic Pain
Interventional: Completed

NCT01768559
Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
Phase III: Type 2 Diabetes
Interventional: Completed

NCT01517412
Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
Phase III: Type 2 Diabetes Mellitus
Interventional: Completed

NCT01147250
Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)
Phase III: Acute Coronary Syndrome
Interventional: Completed

NCT01494987
Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus
Phase III: Type 2 Diabetes Mellitus
Interventional: Completed

NCT01472185
Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus
Phase III: Type 2 Diabetes Mellitus
Interventional: Completed

NCT01555164
A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone
Phase III: Type 2 Diabetes Mellitus
Interventional: Completed

NCT01455896
A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
Phase III: Type 2 Diabetes
Interventional: Completed

NCT01858532
Study Of Diabetic Nephropathy With Atrasentan
Phase III: Diabetic Nephropathy
Interventional: Terminated

NCT01459133
Single Site, Single Subject, Treatment IND With Mannkind Corporation’s Technosphere Inhalation System
Diabetes
Interventional: Withdrawn

NCT00332488
Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT01544881
Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes
Phase I: Type 1 Diabetes Mellitus
Interventional: Completed

NCT01849289
A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes
Phase III: Diabetes, Diabetes Mellitus, Type 2
Interventional: Completed

NCT01620489
Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment
Phase III: Diabetes, Diabetes Mellitus, Type 2
Interventional: Completed

NCT01513590
A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes
Phase III: Diabetes, Diabetes Mellitus, Type 2
Interventional: Completed

NCT01533428
A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)
Phase III: Diabetic Peripheral Neuropathy, Pain
Interventional: Completed

NCT01459809
Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT00379769
RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT01897532
Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)
Phase IV: Diabetes Mellitus, Type 2
Interventional: Completed

NCT01032629
CANVAS – CANagliflozin cardioVascular Assessment Study
Phase III: Diabetes Mellitus, Type 2, Cardiovascular Diseases, Risk Factors
Interventional: Completed

NCT01809327
A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT00968812
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT01106651
A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT01106677
The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis – DPP-4 Inhibitor Comparator Trial)
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT01989754
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
Phase IV: Diabetes Mellitus, Type 2, Albuminuria
Interventional: Completed

NCT01455896
A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
Phase III: Type 2 Diabetes
Interventional: Completed

NCT02863419
Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus
Phase III: Diabetes, Diabetes Mellitus, Type 2
Interventional: Completed

NCT03315143
Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
Phase III: Type 2 Diabetes Mellitus, Chronic Kidney Diseases
Interventional: Active, not recruiting

NCT03548987
Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Phase III: Metabolism and Nutrition Disorder, Obesity
Interventional: Active, not recruiting

NCT03882970
A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes
Phase III: Type 2 Diabetes Mellitus
Interventional: Active, not recruiting

NCT03819153
A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
Phase III: Diabetes Mellitus, Type 2
Interventional: Recruiting

NCT01897532
Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)
Phase IV: Diabetes Mellitus, Type 2
Interventional: Completed

NCT03071692
Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)
Phase III: Type2 Diabetes, Dyslipidemia
Interventional: Recruiting