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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 comparative 12-week study of a new medication for individuals with Type 2 diabetes currently being treated with metformin. Participants must be between the ages of 18 and 70 years and on a stable dose of metformin. Participation will include 8 office visits within a 14-month period. Physical exam, labs and some supplies provided.
  2. A 26-week study evaluating a new, once daily, oral diabetes treatment combined with insulin in adults with Type 1 diabetes. This study requires 12 office visits. Physical exam, labs and some supplies provided.
  3. A study to evaluate dapagliflozin as add-on treatment to insulin therapy in adults (age 18-75) with Type 1 diabetes. Participation will be approximately 15 months with 23 study visits. Physical exam, labs and some supplies provided. (DEPICT2)
  4. A comparative study evaluating efficacy and health outcomes of Toujeo® (newly approved long-acting insulin) compared to available basal insulins. Adult participants must not have been treated previously with insulin. Duration of the study will be 1 year with 4-6 office visits. Physical exam, labs and some supplies provided.
  5. A long-term study to determine the effect of albiglutide (a GLP-1 medication) when added to current diabetes treatment. Participants must have Type 2 diabetes and be at least 18 years of age. This study will last 3-5 years with approximately 20 office visits. Physical exams, labs and some supplies provided. (HARMONY)
  6. A study examining the effectiveness of a new cholesterol medication for reducing the occurrence of major cardiovascular events (e.g. stroke, heart attack or death related to these conditions). The investigation focuses on high risk persons who have had a stroke, heart attack or related condition within the last 5 years. Participants must be at least 18 years old and taking a “statin” medication or be “statin” intolerant. (SPIRE)
  7. A study to investigate the long-term impact of treatment with linagliptin in cardiovascular morbidity, mortality and renal function in a selected population of adult patients with Type 2 diabetes. Study participation could last up to 4 years. Physical exam, labs and some supplies provided. (CARMELINA)
  8. A study comparing efficacy and safety of the morning injection insulin (Toujeo®) versus Lantus® in adults 18-70 years of age with Type 1 diabetes. The duration of the trial is 20 weeks including follow-up visits. There will be 8-10 regular office visits during this time. Physical exam, labs and some diabetes supplies provided. (EDITION JR)
  9. A 6-month study comparing a new glargine-like insulin and Lantus® once daily in children and adolescents with Type1 diabetes with a 6-month extension period. Participants must be between ages 6-17 years, have had diabetes for at least 1 year and not be using an insulin pump. Maximum duration of participation is approximately 58 weeks. Physical exam, labs and some supplies provided.
  10. A study comparing faster-acting insulin aspart, with NovoRapid® both in combination with insulin degludec in children and adolescents with Type 1 diabetes. Participants must be between the ages of 1-18 years. Weight must be at least 49.5 pounds. Study duration will be approximately 44 weeks including screening visits and follow-up visits. There will be at least 16 office visits. Physical exam, labs and some supplies provided. (Onset7)
  11. A study evaluating faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec. Individuals with Type 1 diabetes diagnosed at least one year ago and at least 18 years of age will be evaluated. Total duration of participation is 41 weeks. Physical exam, labs and some supplies provided. (Onset8)

Ongoing Studies:

  1. A devise study evaluating multiple daily injections and continuous glucose monitoring (CGM) in individuals with Type 1 and Type 2 diabetes. (DIAMOND).
  2. A study evaluating the safety and efficacy of a new medication to preserve insulin production and secretion in participants with new onset Type 1 diabetes ages 6-35.
  3. A study evaluating long-term treatment with BELVIQ on the incidence of major adverse cardiovascular events and conversion to Type 2 diabetes in obese and overweight patients with cardiovascular disease. (CARMELLIA)
  4. A trial comparing cardiovascular safety of insulin degludec versus insulin glargine in patients with Type 2 diabetes with high risk of cardiovascular events. (DEVOTE)
  5. A study to evaluate cardiovascular outcomes during treatment with exenatide once-weekly in patients with Type 2 diabetes (EXSCEL).
  6. 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.
  7. A study to demonstrate the superiority of a new medication as adjunct therapy for adults with Type 1 diabetes and inadequate glycemic control with insulin therapy. There are two sub-studies involved with a CGM device and/or DEXA scan included. (inTANDEM)
  8. Two trials assessing efficacy, long-term safety and tolerability of a PCSK9 inhibitor for treatment in subjects with hyperlipidemia or mixed dyslipidemia. (SPIRE)
  9. An open label one-year study comparing Mylan’s glargine-like insulin with Lantus® in patients with Type 1 diabetes with a possible 52-week extension study. (INSTRIDE-1)
  10. Amgen: An open-label extension study to assess the long-term safety and efficacy of a PCSK9 inhibitor for treatment of hypercholesterolemia. (OSLER-2)
  11. A study evaluating the glycemic effects, safety and tolerability of Metformin Delayed Release in participants with Type 2 diabetes.

Upcoming Studies:

  1. A phase 4 study to evaluate Toujeo® and Tresiba in individuals with Type 2 diabetes who are not on insulin.
  2. A phase 3a trial investigating the cardiovascular safety of oral semaglutide in persons with Type 2 diabetes. (PIONEER 6)
  3. A phase 3b study to evaluate a continuous subcutaneous insulin infusion of faster-acting insulin compared to NovoRapid® in adults with Type 2 diabetes. (Onset5)
  4. A phase 3b open label study focusing on patients taking metformin. Compares the effectiveness of combination of metformin with exenatide (delivered by a small device inserted into the skin of the abdomen) to combination with empagloflozin and with glimepiride. (FREEDOM4)
  5. A phase 2a study to determine if golimumab can preserve β-cell function in children and young adults with newly diagnosed Type 1 Diabetes.

 

 

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