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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 phase 2a study to determine if golimumab can preserve β-cell function in children and young adults with newly diagnosed Type 1 Diabetes. Duration of participation is two years. (T1GER)
  2. A phase 3 study to assess whether pemafibrate will reduce 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 greater if female. Duration of participation is 36 weeks. (PROMINENT)
  3. A study focusing on adults with Type 2 diabetes comparing Fast acting insulin aspart to NovoRapid® both in combination with Insulin Degludec and with or without Metformin. Participants must have been diagnosed with diabetes at least ten years ago. (ONSET9)
  4. An observational 18-week study of adult patients with hypothyroidism switching from levothyroxine to desiccated thyroid extract.
  5. A 52-week project evaluating the efficacy and safety of Sotagliflozin in adults with Type 2 diabetes who are inadequately controlled taking basal insulin alone or taking basal insulin in addition to one or two oral antidiabetic medications. There is also a CGM (continuous glucose monitor) sub-study. (SOTA-INS)
  6. A 1-2-month trial to evaluate safety and tolerability of 4 oral doses of a new study medication involving individuals having diabetes with renal disease. At screening, participants must be male and 18 years old or older, or surgically sterile females or postmenopausal females older than 45 years of age.
  7. A new study to compare the immunogenicity, efficacy and safety of the investigational medication insulin glargine injection to Lantus® in adults with Type 1 diabetes. Study duration is 26 weeks. Participants must be 18 to 75 years of age. A history of a stable regimen of insulin (6 months) is required. (GLITTER1)
  8. A comparison study of Sotagliflozin and Empagliflozin involving adults with Type 2 diabetes which is inadequately controlled on a DPP-4. (SOTA-EMPA)
  9. A comparison study involving adults with Type 2 diabetes who take metformin only and who will add either Sotagliflozin or Glimepiride to their medication regimen. (SOTA-GLIM)
  10. A clinical study focused on adults with Type 1 diabetes comparing the efficacy and safety of a new medication produced by two manufacturing processes.  

Ongoing Studies:

  1. A 6-month study comparing a new glargine-like insulin and Lantus® once daily in children and adolescents with Type1 diabetes. There is a possible 6-month extension period. (EDITION JR)
  2. A phase 3b clinical trial studying the addition of liraglutide to SGLT2 treatment in adult subjects with Type 2 diabetes. (LIRA-ADD2SGLT2)
  3. 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)
  4. A study evaluating long-term treatment with BELVIQ on the incidence of major cardiovascular events and conversion to Type 2 diabetes in obese and overweight patients with cardiovascular disease. (CARMELLIA)
  5. A study to evaluate dapagliflozin as add-on treatment to insulin therapy in adults ages 18-75 years having Type 1 diabetes. (DEPICT2)
  6. A long-term study to determine the effect of albiglutide (a GLP-1 medication) added to current treatment of Type 2 adult diabetes. (HARMONY)
  7. A study to assess cardiovascular outcomes following treatment with a new SGLT-2 class medication in patients with Type 2 diabetes and established vascular disease. (VERTIS CVO)
  8. A comparative study evaluating efficacy and health outcomes of Toujeo® (newly approved long-acting insulin) compared to available basal insulins.
  9. A phase 3a trial investigating the cardiovascular safety of oral semaglutide in adults with Type 2 diabetes. (PIONEER 6)

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 open-label study comparing the new insulin lispro injection to Humalog® in adults with Type 2 diabetes. (GENTL 2)
  3. A 24-week evaluation of empagliflozin and linagliptin in children and adolescents with Type 2 diabetes. There is an extension period lasting up to 52 weeks.
  4. An evaluation of the effects of semaglutide on the risk of major cardiovascular events for individuals with Type 2 diabetes and a high risk of such events (SOUL). 

 

 

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