Ongoing Diabetes Research Studies

A lab technician analyzes the results of a lab specimen

Research is key to treatment of diabetes. At the Texas Diabetes Institute, we take our research very seriously. The following studies are currently being conducted:

  • Type 2 Diabetes
  • Non-Diabetic
  • Pre-Diabetes/at-Risk of Diabetes 

If would like more information on our current research studies or have questions about TDI diabetes research please call 210-358-7200

Type 2 Diabetes

Durability of Early Combination Therapy vs. Conventional Therapy in New Diabetes

Triple Therapy Study - HSC20080456H
Principal Investigators: DeFronzo

Purpose: To compare the efficacy of two different therapeutic regimens for the treatment of individuals with newly diagnosed diabetes.

Eligibility:

  • Newly diagnosed (<2 years) type 2 diabetes
  • May be taking Metformin

This study will enroll approximately 600 study participants with type 2 diabetes, and it will continue for a period of 3 years.

If you would like more information on this research study or have questions about TDI diabetes research please call 210-358-7200.


Dapa/Saxa Study – HSC20150742
Principal Investigators: Drs. DeFronzo/Cersosimo

Purpose: A 16-week, single, randomized, double-blind, active-controlled, parallel group, phase 3b trial to evaluate the efficacy of saxagliptin co-administered with dapagliflozin compared to dapagliflozin with regard to endogenous glucose production in adult patients with type 2 diabetes who have insufficient control on metformin or metformin/sulfonylurea therapy.

Eligibility:

  • 18-70 years of age
  • Type 2 diabetic mellitus
  • Currently on metformin or metformin/sulfonylurea for at least 8 weeks
  • HbA1c ≥7.5 ≤11.0mg/dL
  • Must be able to take oral medications
  • In good general health

A 16-18 week long clinical trial study.

If you would like more information on this research study or have questions about TDI diabetes research please call 210-358-7200.


NIH-Protocol 2 study – HSC20150668H
Principal Investigators: Dr. DeFronzo

Purpose: Decrease in plasma glucose concentration for change in islet hormone (glucagon/insulin) secretion. SGLT2 inhibition and stimulation of endogenous glucose production-protocol 2: elucidation of mechanisms responsible for the increase in EGP following SGLT2.

Eligibility:

  • Must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent
  • May be of either sex male or female
  • 18-70 years of age
  • Body Mass Index: 25< BMI <45 kg/m^2
  • AST (SGOT) < 3 times upper limit of normal
  • ALT (SGPT) < 3 times upper limit of normal
  • Stable weight +/- 3 lbs. within the last 3-4 months
  • Females may be taking stable dose of Estrogen or other hormonal replacement therapies
  • Metformin and/or Sulfonylurea and/or combination (stable dose for 3 months)

If you would like more information on this research study or have questions about TDI diabetes research please call 210-358-7200.


AZ Dapa-Pancreatic Study – HSC20160586H/P20685
Principal Investigators: Drs. DeFronzo and Eugenio

Purpose: In this study, the researchers hope to define the role of increased plasma glucagon, decline in plasma insulin, and fall in plasma glucose concentration. We will examine whether the signal for the increase in endogenous glucose production caused by glucosuria is mediated via the decrease in plasma glucose and insulin concentration, or by the increase in plasma glucagon concentration.

Eligibility:

  • Type 2 diabetic mellitus
  • 18-70 years of age
  • BMI: 21-45 kg/m^2
  • Must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, EKG and urinalysis
  • Stable body weight +/- 3 lbs. over the preceding 3 months
  • Subjects not in an excessively heavy exercise program

If you would like more information on this research study or have questions about TDI diabetes research please call 210-358-7200.


AZ Dapa-Exenatide (P4) – HSC20160597H/P20693
Principal Investigators: Drs. DeFronzo and Eugenio

Purpose: To examine the effect of chronic exenatide (4 months) therapy on beta cell function and insulin sensitivity and the role it plays to decrease the elevation in plasma glucagon level observed in SGLT2 inhibition.

Eligibility:

  • Type 2 diabetic mellituswith HbA1c > 7.0% and < 10.0%
  • 18-70 years of age
  • BMI: 21-45 kg/m^2
  • Must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, Lipids, urinalysis, urine albumin/Creatinine ratio, and EKG
  • Stable body weight +/- 3 lbs. over the preceding 3 months
  • Subjects not in an excessively heavy exercise program
  • May be taking no medications or on Metformin and/or Sulfonyluria for at least 3 months

If you would like more information on this research study or have questions about TDI diabetes research please call 210-358-7200.

Pre-Diabetes/at-Risk of Diabetes

ADA Pre-Diabetes Study - HSC 20130414
Principal Investigators: Drs. DeFronzo/Cersosimo/Curtis Triplitt

Purpose: Preservation of Beta Function in pre-diabetes in subject with Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT).

Eligibility:

  • Ages 18-65
  • Normal Healthy subjects without Family History of diabetes in a first degree relative.
  • BMI=24-40 kg/m2
  • Stable body weight
  • Able to take oral medications

A 2 year long clinical trial study.

If you would like more information on this research study or have questions about TDI diabetes research please call 210-358-7200.

Pediatric

TODAY Genetics - HSC20090028H

Purpose: To better understand type 2 diabetes in the pediatric population.

Eligibility:

  • 18> years of age at the time of type 2 diabetes diagnosis
  • Willing to give DNS sample

The study requires a small blood draw (about 2 tablespoonfuls) and an interview about your family and medical history. The visit will take about an hour.

If you would like more information on this research study visit the TODAY study website or have questions about TDI diabetes research please call 210-358-7200.


WelChol Study - HSC20110050H

Purpose: To study the safety and effectiveness of the approved medication Colesevelam as monotherapy or an add-on therapy with Metformin for improved glycemic control with type 2 diabetes.

Eligibility:

  • 10-17 years of age at the time of type 2 diabetes diagnosis

If you would like more information on this research study or have questions about TDI diabetes research please call 210-358-7200.


TrialNet Natural History Study - HSC20060084

Purpose: TrialNet offers a blood test that can identify increased risk for type 1 diabetes up to 10 years before symptoms appear. This test looks for certain markers in the blood (called autoantibodies) that signal an increased risk for the disease.   

Eligibility:

  • Age 45 years and younger with a parent, brother, sister, or child with type 1 diabetes
  • Age 20 years and younger with a niece, nephew, aunt, uncle, grandparent, half-brother, half-sister, or cousin with type 1 diabetes

If you have a relative with type 1 diabetes, your chances of being diagnosed with the disease are 15 times greater than a person with no family history of the disease. If you have any questions or are unsure about whether to have your family screened, please contact a TrialNet representative.

If you would like more information on this research study or have questions about TDI diabetes research please call 210-358-7200.