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.
- 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)
- 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)
- 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)
- An observational 18-week study of adult patients
with hypothyroidism switching from levothyroxine to
desiccated thyroid extract.
- 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)
- 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.
- 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)
- A comparison study of Sotagliflozin and
Empagliflozin involving adults with Type 2 diabetes
which is inadequately controlled on a DPP-4. (SOTA-EMPA)
- 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)
- 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:
- 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)
- A phase 3b clinical trial studying the
addition of liraglutide to SGLT2 treatment in
adult subjects with Type 2 diabetes.
(LIRA-ADD2SGLT2)
- 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)
- 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)
- A study to evaluate dapagliflozin as add-on
treatment to insulin therapy in adults ages
18-75 years having Type 1 diabetes. (DEPICT2)
- A long-term study to determine the effect of
albiglutide (a GLP-1 medication) added to
current treatment of Type 2 adult diabetes.
(HARMONY)
- 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)
- A comparative study evaluating efficacy and
health outcomes of Toujeo® (newly approved
long-acting insulin) compared to available basal
insulins.
- A phase 3a trial investigating the
cardiovascular safety of oral semaglutide in
adults with Type 2 diabetes. (PIONEER 6)
Upcoming Studies:
- An open-label study comparing the new
insulin lispro injection to Humalog® in adults
with Type 1 diabetes. (GENTL 1)
- An open-label study comparing the new
insulin lispro injection to Humalog® in adults
with Type 2 diabetes. (GENTL 2)
- 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.
- 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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