Clinical Trials

Clinical trials are studies designed to find new and better ways to treat patients with diabetes. The physicians at the University of Maryland Center for Diabetes and Endocrinology are currently conducting the clinical trials listed below.

Official Title:

A randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of empagliflozin (10 mg, 25 mg) administered orally, once daily over 24 weeks in hypertensive black/African American patients with type 2 diabetes mellitus

Trial No.: 1245.29

Purpose:

The purpose of the study is to determine if empagliflozin reduces blood sugars and blood pressure in African Americans who have type 2 diabetes and high blood pressure.

Investigator(s):

Kristi Silver, M.D.

Requirements:

You may be able to take part in this study if you:

  1. Are at least 18 years old
  2. Are African American
  3. Have Type 2 Diabetes
  4. Have high blood pressure

Participation:

  • 10 visits* and 1 telephone call over approximately 29 weeks.
  • At 1 or more of the study site visits, you will.
  • Undergo a medical exam and have blood taken for laboratory tests.
  • Take study drug for 24 weeks.
  • Perform 24 hour home blood pressure monitoring 3 times during the study.

If you qualify, you will receive study-related care and study medication at no charge.

*Additional study visits may be required if a laboratory test must be repeated.

Contact:

Tameka Alestock (talestoc@medicine.umaryland.edu), 410-706-6430

Official Title:

A Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of once daily, oral doses of Empagliflozin as Adjunctive to inSulin thErapy over 26 weeks in patients with Type 1 Diabetes Mellitus (EASE-3) Trial No: 1245.72

Purpose:

The purpose of this study is to determine the tolerability and blood sugar lowering effects of the investigational drug, empiglaflozin, in combination with insulin in people with type 1 diabetes.

Investigator(s):

Kristi Silver, M.D.

Requirements:

  1. 18 years of age or older
  2. Insulin dependent type 1 diabetes for at least a year
  3. HbA1c level between 7.5%-10%
  4. Willing to take a study medication in addition to your insulin therapy

Additional research study criteria will be evaluated by a study doctor to determine if you qualify.

Access to Study Website with pre-screening questions can be found at: www.easediabetesstudy.com/ease3

Participation:

  • 10 visits and 1 telephone call over 28 weeks
  • Take study drug for 26 weeks
  • Medical exams and blood for laboratory tests
  • Monitor fingerstick blood sugars at least 4 times a day
  • Check ketones daily

If you qualify, you will receive study-related care and study medication at no charge.

Contact:

Tameka Alestock (talestoc@medicine.umaryland.edu), 410-706-6430

Official Title:

A Case-Finding Approach to Screening for Monogenic Diabetes

Purpose:

The purpose of our study is to develop a better way to identify patients with monogenic diabetes. Monogenic diabetes is a special type of diabetes that is caused by a change in a single gene. The more common type 1 and 2 diabetes are caused by a combination of several genetic and non-genetic factors. Many people with monogenic diabetes do not know they have it. Proper diagnosis of monogenic diabetes can lead to:

  1. Better and easier sugar control
  2. Improved quality of life
  3. Identification of family members who are at risk for diabetes

Investigator(s):

Toni Pollin Ph.D. and Elizabeth Streeten M.D.

Requirements:

There are certain features that point to an increased chance of having monogenic diabetes. You may be eligible for the study if you fit at least one of the following categories:

  1. Diabetes diagnosed before one year of age; or
  2. Type 1 diabetes and a parent or child with type 1 diabetes; or
  3. Diabetes other than Type 1 diagnosed at 30 years of age or less; or
  4. Type 2 diabetes diagnosed by 45 years of age, not extremely overweight at diagnosis, and 2 or more relatives diagnosed with diabetes by 50 years of age; or
  5. Diabetes along with other features, such as birth defects, intellectual disability, deafness or blindness; or
  6. Lean and have or have had gestational diabetes; or
  7. Diabetes suspected by your physician to be monogenic or unusual in some way

Participation:

1 to 3 study visits

Visits include a complete medical and family history, completion of questionnaires and a small blood draw. Financial compensation is provided for your time and effort.

Contact:

Mickaela Nicholson at 410-706-6140 or email ppgm@medicine.umaryland.edu

Official Title:

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction: GLP-1 and Hypoglycemia

Purpose:

To determine the effects the GLP-1 on hypoglycemia associated autonomic dysfunction and endothelial function.

Investigator(s):

Stephen N. Davis MBBS and Nino Joy, MD

Requirements:

Adult, non-smokers with no diabetes or type 2 diabetes (A1C >5.5% , and diabetes duration <20yrs), generally healthy without significant cardiovascular disease, without history of pancreatitis, age 18-60, BMI >20

Participation:

Two 1 day overnight (inpatient) stays separated by 2 months each. Sequence of visits are randomized. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.

Contact:

Nino Joy, MD, 410-706-5643

Official Title:

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction: Differing Levels of Hypoglycemia

Purpose:

To determine the effects of different levels of hypoglycemia on associated autonomic dysfunction and endothelial function.

Investigator(s):

Stephen N. Davis MBBS and Maka Hedrington, MD

Requirements:

Adult, non-smokers with no diabetes, generally healthy without significant cardiovascular disease, age 18-60, BMI >20

Participation:

Four separate 1 day overnight (inpatient) stays separated by 2 months each. Sequence of visits is randomized. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.

Contact:

Maka Hedrington, MD, 410-706-5623

Official Title:

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction: Dose Response of Epinephrine

Purpose:

To determine the effects of different dose responses of epinephrine on associated autonomic dysfunction and endothelial function.

Investigator(s):

Stephen N. Davis MBBS and Maia Mikeladze, MD

Requirements:

Adult, non-smokers with no diabetes, generally healthy without significant cardiovascular disease, age 18-60, BMI >20

Participation:

Four separate 1 day overnight (inpatient) stays separated by 2 months each. Sequence of visits is randomized. All labs and medications are provided by the study sponsor. Financial compensation is also provided for time and inconvenience.

Contact:

Maia Mikeladze, MD, 410-706-5626

For more information or to schedule an appointment call 855-979-8667.