Clinical Trial Studies

Adult Studies

TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM) (TTEDD). Study details on clinicaltrials.gov.
The purpose of this study is to optimize several multi-dose regimens of TRX4, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of TRX4 against standard safety and efficacy parameters.
Phase 2

Eligibility: Type 1, GAD autoantibody positive,  age 19-45, BMI less than 35
Miscellaneous:  8 days dosing, no overnight stays

For information, please contact:

Marianne Vetrano, R.N. / 934-4112 / This email address is being protected from spambots. You need JavaScript enabled to view it.

Tiffany Grimes, R.N. / 934-4112 / This email address is being protected from spambots. You need JavaScript enabled to view it.


Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus.  Study details on clinicaltrials.gov.
The purpose of this study is to determine the safety of BHT-3021 injections given weekly for 12 weeks and to evaluate the effect of BHT-3021 on antibody and immune (T cell) responses to autoantigens (e.g. insulin). Changes in pancreatic beta cell function, insulin requirements and blood glucose levels will also be evaluated.
Phase 1

Eligibility: Type 1, autoantibody positive, within 5 years of diagnosis, age 19-40, BMI less than 31

For information, please contact:

Marianne Vetrano, R.N. / 934-4112 / This email address is being protected from spambots. You need JavaScript enabled to view it.

Tiffany Grimes, R.N. / 934-4112 / This email address is being protected from spambots. You need JavaScript enabled to view it.


A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's SyndromeStudy details on clinicaltrials.gov.
Patients will receive Corlux (mifepristone) daily for up to 24 weeks. Assessments of the signs and symptoms of Cushing's syndrome will be obtained.
Phase 3

Eligibility: Cushings, age 19 and older

For information, please contact:

Marianne Vetrano, R.N. / 934-4112 / This email address is being protected from spambots. You need JavaScript enabled to view it.

Tiffany Grimes, R.N. / 934-4112 / This email address is being protected from spambots. You need JavaScript enabled to view it.


Targeting INflammation Using SALsalate in Type 2 Diabetes (TINSAL-T2D).  Study details on clinicaltrials.gov.  
Growing evidence over recent years supports a potential role for low grade chronic inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we will determine whether salsalate, a member of the commonly used Non-Steroidal Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2 diabetes. The study will determine whether salicylates represent a new pharmacological option for diabetes management. The study is conducted in two stages. The primary objective of the first stage is to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The primary objective of Stage 2 of the study is to evaluate the effects of salsalate on blood sugar control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and cardiac risk.
Phase 2/3

Eligibility:  Type 2, age 19-75
Miscellaneous:  No pre-existing chronic tinnitus; no microalbuminuria; no anticoagulants; no Plavix or Persantine

For information, please contact:

Marianne Vetrano, R.N. / 934-4112 / This email address is being protected from spambots. You need JavaScript enabled to view it.

Tiffany Grimes, R.N. / 934-4112 / This email address is being protected from spambots. You need JavaScript enabled to view it.


TECOS:  A Randomized, Placebo Controlled Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Mono- or Dual Combination oral Antihyperglycemic TherapyStudy details on clinicaltrials.gov.
The primary study objective is to compare the including sitagliptin as part of usual care versus usual care without sitagliptin (or other DPP-4 inhibitors or CLP-1 analogues) upon cardiovascular events.
Phase 3

Eligibility:  Adults over the age of 50 with type 2 diabetes receiving metformin, pioglitazone, or a sulfonylurea as monotherapy or in combination at least 3 months with a hemoglobin A1c of 6.5 or greater but equal to or less than 8.0 and a history of cardiovascular disease.

For information, please contact:

Miriam Rueger / 975-8217 / This email address is being protected from spambots. You need JavaScript enabled to view it.

Dana Rigsgy / 996-4015 / This email address is being protected from spambots. You need JavaScript enabled to view it.