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Clinical Research Studies

As an independent facility, we work with a broad spectrum of sponsors to assist each of them with their clinical research. Our areas of investigation include medical therapies for the prevention and/or treatment of the following conditions:

  • Diabetes: Types 1 and 2
  • Diabetic complications
  • Hyperlipidemia
  • Obesity
  • Osteoporosis
  • Thyroid disease
  • Erectile disfunction
  • Hormone deficiency in men and women
  • Infertility
  • Growth Hormone deficiency in children and adults
  • Acromegaly

In addition, we have conducted studies on the long term cardiovascular safety of various medications. Our close association with subspecialists in other medical fields has also provided opportunities to participate in clinical studies involving such conditions as depression and anxiety.

The sections below contain information about the wide range of research in which we are involved at this time.

Studies Now Enrolling:

We are now interviewing individuals who are interested in participating in one of the clinical studies listed below. The health condition of a potential participant must meet the criteria discussed in the specific study description. During the research period, all physical examinations, lab services and study medications are provided free of charge. Additionally, in certain studies, some of a participant’s routine medication may be covered. In diabetes studies, the cost of a glucose meter and test strips may be covered as well. Most study sponsors also offer a stipend to participants to help compensate for travel expenses.

To see the “Participant Questionnaire”, click here. If you have questions, please call our office at 214-265-2137.

  1. A 24-week study evaluating the efficacy of empagliflozin and linagliptin in children and adults with type 2 diabetes. An extension period could last up to 52 weeks.
  2. A phase 3 study to assess whether pemafibrate will reduce the incidence of adverse cardiovascular events by lowering triglycerides in patients with type 2 diabetes. Participants must be 50 years of age or older if male and 55 or older if female. Duration of participation is 36 weeks. (PROMINENT)
  3. An evaluation of the safety and tolerability of 4 oral doses of a new study medication for individuals with diabetes and renal disease. Study duration is 1-2 months. Male participants must be at least 18 years of age. Female participants must be surgically sterile or at least 45 years old and postmenopausal.
  4. A study evaluating Sotagliflozin compared to Empagliflozin in adult type 2 diabetes that is inadequately controlled on a DPP-4. (SOTA-EMPA)
  5. A type 1 diabetes study, focusing on adults, which compares the immunogenicity, efficacy and safety of the investigational insulin glargine injection to Lantus®. (GLITTER1)
  6. An evaluation of effects and safety of semaglutide once-weekly as adjunct to intensive behavioral therapy in subjects who are overweight or obese. Participation duration is 75 weeks.
  7. A 75-week study evaluating effects and safety of semaglutide once-weekly in overweight or obese subjects.
  8. A 14-month study of Continuous Glucose Monitoring in type 2 diabetic individuals using basal insulin.  

Ongoing Studies:

  1. A clinical trial comparing the efficacy and safety of a new long-acting insulin preparation produced by two manufacturing processes. The study focuses on adults with type 1 diabetes.
  2. A comparison of fast acting insulin aspart to NovoRapid® both in combination with insulin Degludec, with or without Metformin in adults with type 2 diabetes. (ONSET9)
  3. A phase 2a study to determine if golimumab can preserve β-cell function in children and young adults with newly diagnosed type 1 diabetes. Participation duration is 2 years. (T1GER)
  4. An investigation comparing a new glargine-like insulin and Lantus® once daily in children and adolescents with type 1 diabetes. Study duration is 6 months with a 6-month extension period. (EDITION JR)
  5. A phase 3b study evaluating semaglutide once weekly injection as an add-on therapy to SGLT-2 medications in adult subjects with type 2 diabetes. (SUSTAIN9)
  6. An assessment of cardiovascular outcomes following treatment with a new SGLT-2 class medication in patients with type 2 diabetes and established vascular disease. (VERTIS CVO)
  7. A study evaluating efficacy and health outcomes with the use of Toujeo® (a long-acting insulin) compared to available basal insulins.
  8. A phase 3a clinical trial investigating the cardiovascular safety of oral semaglutide in adults with type 2 diabetes. (PIONEER 6) 9. A 52-week evaluation of the efficacy and safety of Sotagliflozin in adults with type 2 diabetes which is inadequately controlled using basal insulin alone or in combination with up to two oral antidiabetic medications. There is also a Continuous Glucose Monitoring sub-study. (SOTA-INS)  

Upcoming Studies:

  1. An open-label study comparing the new insulin lispro injection to Humalog® in adults with type 1 diabetes. (GENTL 1)
  2. An evaluation of the effects of Semaglutide on cardiovascular events in individuals who are overweight or obese. (SELECT)
  3. An open-label trial comparing a new study medication with Novolog® in controlling type 1 diabetes.
 

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