Overseen ByRalph DeFronzo, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Waitlist Available
Sponsor: The University of Texas Health Science Center at San Antonio
Trial Summary
What is the purpose of this trial?This trial tests a new drug that blocks glucagon, a hormone that raises blood sugar. It targets Type 2 Diabetes patients whose blood sugar is not well-controlled with current treatments. The drug aims to lower and stabilize blood sugar levels by preventing glucagon from working.
Eligibility Criteria
This trial is for Type 2 diabetes patients aged 18-70 with a BMI of 25-40 kg/m2 and HbA1c levels between 7.5-10%. Participants must be on stable diabetes medication, if any, for at least three months. Women must use contraception or be post-menopausal/surgically sterilized. Exclusions include major organ disease, significant heart/pulmonary issues, psychiatric disturbances, recent weight fluctuation, certain medications affecting insulin sensitivity, and contraindications to MRI.Inclusion Criteria
I am a woman not breastfeeding, either post-menopausal, using birth control, or sterilized.
I am between 18-70 years old, have Type 2 diabetes, my BMI is between 25-40, and my HbA1c is between 7.5-10%.
I have been on the same diabetes medication dose for at least 3 months.
I have Type 2 Diabetes and am either not on medication or only take metformin, sulfonylureas, or SGLT-2 inhibitors.
I can communicate clearly and can legally consent to participate.
Exclusion Criteria
I haven't used certain diabetes medications for more than a week in the last year.
I do not have serious heart, blood vessel, or lung problems.
I or my family have a history of specific pancreatic or endocrine tumors.
I am unable to give my written consent voluntarily.
I do not have any major organ diseases as per my recent tests and exams.
I have not been treated with GLP-1 receptor agonists or insulin.
I do not have type 1 diabetes.
Participant Groups
The study tests REMD-477's effects on glucose tolerance and insulin sensitivity in liver, muscle, adipocytes (fat cells), beta cell function (insulin-producing cells), and inflammation in fat tissue among T2DM patients. It compares the drug against a placebo through subcutaneous injections to evaluate its potential benefits.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Glucagon Receptor Agonist (GRA) REMD-477 groupExperimental Treatment1 Intervention
Participants are assigned to a 12 week treatment of REMD-477
Group II: Placebo groupPlacebo Group1 Intervention
Participants are assigned to a 12 week course of placebo for REMD-477
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Texas Diabetes InstituteSan Antonio, TX
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Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor