Study Details

Open

Type 2 Diabetes Study

We're doing this study to learn if a new investigational treatment can help people with type 2 diabetes who may have too much of a stress hormone called cortisol in their body. Too much cortisol can make it harder to control blood sugar. This study will test if lowering cortisol helps people with diabetes feel better and manage their blood sugar more easily.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

In the first part of the study, you would be screened for elevated cortisol using a simple overnight test. You may be asked to have a non-contrast CT scan of your adrenal glands. In the second part of the study, you would be asked to take the study medication (or placebo) once daily by mouth for 24 weeks. Throughout the study, you would be asked to attend regular study visits, complete questionnaires, use a continuous glucose monitor (CGM) and a home blood pressure monitor to track your health between visits, measure your blood sugar and urine ketones at home as instructed, provide saliva samples at home and bring them to clinic visits, and undergo blood draws at multiple time points to monitor safety and effectiveness of the investigational treatment.

Incentives

Information provided upon request, Study medication

In-person visits:
8-9

Phone or online visits:
3-4

Total length of participation:
6-7 months

Looking for Specific Volunteers

Able to participate:

you have type 2 diabetes diagnosed at least 1 year ago
you have an HbA1c of 7.5% or higher
you are taking 2 or more diabetes medications
you have high blood pressure, diabetes complications, or are using insulin or GLP-1 agonists
you are unable to become pregnant or willing to use approved contraceptive methods

Not eligible if:

you have type 1 diabetes, LADA, or MODY
you have significant renal impairment or liver disease
you have untreated or poorly controlled: moderate-to-severe sleep apnea, major depressive disorder, bipolar disorder, PTSD, schizophrenia, hyperthyroidism or hypothyroidism
you have uncontrolled hypertension have had recent severe hypoglycemic events
you use certain medications that are prohibited (including oral or injectable glucocorticoid steroids such as prednisone or cortisone acetate)

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Eastowne Medical Office Building
100 Eastowne Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

John Buse
Medicine-Endocrinology

Study Type

Clinical or Medical
Interventional

Study Topics

Diabetes

IRB Number

25-2734