Ongoing Diabetes Research Studies

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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.


ORAMED - HSC20140476H
Principal Investigators: Dr. DeFronzo

Purpose: To gain information about the absorption of oral insulin and its effect on hepatic and peripheral glucose metabolism in Type 1 Diabetes patients.

Eligibility:

  • 18-70 years of age
  • Type 1 DM
  • A1C>7%<10%
  • In good general health
  • BMI= 18-40 kg/m2

A 3-6 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.


The Glycemia Reduction Approaches in Diabetes(Grade); A Comparative Effectiveness Study

Grade Study - HSC20130205H
Principal Investigators: Drs. DeFronzo/Cersosimo/Curtis Trilpitt

Purpose: To explore which medication to add in type 2 diabetes mellitus patients after lifestyle and metformin are not adequately controlling blood glucose levels.

Eligibility:

  • >30 years of age at time of diabetes diagnosis
  • Diagnosis with diabetes
  • HbA1c>6.8%
  • Taking a daily dose of >1000 mg metformin
  • Willing to administer daily subcutaneous injections and take a second diabetes drug
  • Not taking any other diabetes drug within 6 months
  • No major cardiovascular event in previous year, no severe liver disease, renal disease or anemia

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


Cycloset & GLP 1 RA Study 
Principal Investigators: Drs. DeFronzo/Cersosimo/Curtis Triplitt

Purpose: To better understand how this new drug (Cycloset) Lowers Blood Sugar.

Eligibility:

  • 30-70 years of age
  • Type 2 diabetic mellitus
  • HbA1c >7.5 - 10.0%
  • BMI=24-40 kg/m2
  • Taking a stable dose of exenatide (2mg/week) or liraglutide (1.2-1.8mg/day)

A 4 month 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.


Canaglifozin Mechanism of Action-Janssen Study - 20140322H
Principal Investigators: Dr. DeFronzo

Purpose: Effect of combined incretin-based therapy plus canagliflozin on glycemic control and the compensatory rise in hepatic glucose production in Type 2 Diabetes patients.

Eligibility:

  • 18-70 years of age
  • Type 2 diabetic mellitus
  • Metformin stable dose for 3 months
  • A1C>7%<10%
  • Stable weight
  • Must be willing to inject

A 5-6 month 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.


Elcelyx Study LCRM 112 - HSC 20150628H
Principal Investigators: Drs. DeFronzo/Cersosimo

Purpose: A randomized, double-blinded , parallel group, multicenter, placebo-controlled, dose-ranging study to evaluate the glycemic effects, safety, and tolerability of metformin delayed-release in subjects with type 2 diabetes mellitus.

Eligibility:

  • At least 25 years of age
  • Type 2 diabetic mellitus
  • A1C >7.5% - 10.5%
  • Currently on metformin (must wash out for 60-75 days) or drug naive
  • BMI= 20.0-45.0 kg/m2
  • Stable body weight
  • Must be able to take oral medications

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/sulfolnylurea 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.

Non-Diabetic

Characterization of Metabolic Defects in Arab and Mexican American Subjects at Increased Risk of Type 2 Diabetes.

Arab and Mexican American Study - HSC20110352H
Principal Investigators: Cersosimo/Abdul-ghani

Purpose:To explore the metabolic defects that may lead to the development of type 2 diabetes in Arab versus Mexican Americans.

Eligibility:

  • Ages 18-70
  • Mexican American ethnicity
  • BMI<26 or >30 for normal healthy subjects
  • General good health

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


The Role of Glucose Mediated Glucose Uptake in the Pathogenesis of IFG and IGT.

Tube and Naso-jejunal Meal Tolerance Test - HSC20130028H

Purpose:To study the metabolic abnormalities responsible for the development of Impaired Fasting Glucose (IFG).

Eligibility:

  • Ages 18-70
  • Healthy non-diabetic subjects
  • Stable medication dose for the past 3 months
  • Stable weight for the past 3 months
  • Hematocrit >33%

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.