GLP1 Brain MR

16 Mar GLP1 Brain MR

In recent years a new group of medications to control blood sugar have been approved by the FDA. These “GLP1-RA” drugs have been proven to work well on lowering blood sugars and improving the health of patients with Type 2 Diabetes. Early data also indicates that there may be benefits beyond blood sugar control. We have designed this study to answer if this new type of diabetes medication changes the way blood moves in and around the brain. You are being asked to participate in this clinical trial because you are taking blood sugar control medications to treat your Type 2 Diabetes but you are not taking the type of drug we want to study.

This is a clinical trial of semaglutide (Ozempic®). Semaglutide is approved by the FDA for use in patients with Type 2 Diabetes.
By doing this trial, we hope to learn:
– if semaglutide has a measurable effect on the blood flow and blood vessels of the brain
– if semaglutide has a measurable effect on certain markers in the blood

If you decide to be in this trial, you will be assigned to take either semaglutide or a placebo for 12 months. You will not know whether you are taking semaglutide or the placebo. They look the same. You will be assigned to semaglutide or the placebo by a computer. You will have an equal chance of receiving one or the other. The study PI and most of the research team will not know whether you are taking semaglutide or the placebo. The study pharmacist and study endocrinologist will know what you are taking and can share this information if it is needed in order to take care of you.

Semaglutide and the placebo are injections once a week for the 12 months. Before the first dose we will have you complete a contrast enhanced MRI scan of the blood vessels in your brain. We will repeat this scan at the end of the study to see if there are any differences in these scans. During the 12 months between the scans we will ask you to come for regular visits where vital signs and blood samples will be collected as well as a brief interview to see if you have any health changes or problems with the study drug.

There is a chance that the study procedures and semaglutide could cause you some harm (side effects). We describe these in writing in detail before starting the study.

During the study only, we ask that you don’t take any drug that works the same way as the study drug. This protects you from “doubling” the dose. If your regular physician requests you stop or start any medication we will follow their lead and you may stop study participation if your physician prescribes you semaglutide or another GLP1-RA drug.

Possible risks of participating in this study include rare but serious risks such as allergic reactions to the study drug or the contrast agent used for the MRI, pancreas inflammation, and very low blood sugar. More common and less serious risks include nausea, vomiting, diarrhea, abdominal pain, and constipation. Pregnant and breast-feeding people are not included in this study. If you are able to become pregnant, you will have your urine tested for pregnancy before enrollment into the study and before each MRI scan. You must agree to avoid pregnancy with effective contraception until 2 months after you have stopped the study drug.

You don’t have to be in this study. It may be that your usual physician would prescribe the study drug we are using without being in the study. We encourage you to talk with your doctor about the study and study drug prior to beginning the study treatment. We will ask your permission to notify your usual physician(s) about your participation.

Participant Eligibility

INCLUSION:
(1) Men and women 40-65 years of age
(2) Subjects with type-2 diabetes >= 3 years and HbA1C 7%-10% with blood sugar control medications including insulin, metformin, sulfonylureas, or SGLT2 inhibitors
(3) Medically stable
(4) Has not received any investigational drug in the past 6 months
(5) Willing to participate and sign informed consent.

EXCLUSION:
(1) Contraindication to MRI or contrast agent
(2) eGFR<45 mL/min/1.73m2 (eGFR is a measurement of kidney function)
(3) Currently treated with GLP-1 receptor antagonist (same drug class as study intervention)
(4) Unable to perform home-glucose monitoring
(5) Currently need more than 100 units of insulin daily
(6) Uncontrolled hypertension with systolic blood pressure (SBP)>180 mmHg or diastolic blood pressure (DBP)>100 mmHg
(7) LDL-C>130 mg/dL or not on stable statin therapy in the past 6 months
(8) Treatment with pioglitazone in the past 3 months
(9) History of pancreatitis
(10) History of MI, stroke or TIA
(11) History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
(12) Hypersensitivity to semaglutide or any of the product components
(13) Participating in other clinical trial
(14) Women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who have a positive pregnancy test at enrollment or who are breastfeeding or who plan to become pregnant in the next 15 months

Contact

Daniel Isquith
(206) 744-8308