Effect of Novel Glucagon Receptor Antagonist REMD-477 on Glucose and Adipocyte Metabolism in T2DM (NCT05093517) | Clinical Trial Compass
CompletedEarly Phase 1
Effect of Novel Glucagon Receptor Antagonist REMD-477 on Glucose and Adipocyte Metabolism in T2DM
United States4 participantsStarted 2021-11-10
Plain-language summary
With REMD's glucagon receptor antagonist, the study team propose to provide a comprehensive examination of the effect of elevated plasma glucagon concentrations in Type 2 Diabetes Mellitus (T2D) patients on:
(i) glucose tolerance; (ii) insulin sensitivity in liver, muscle, and adipocytes; (iii) beta cell function; (iv) adipocyte inflammation.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Type 2 diabetic subjects, males/females;
✓. age = 18-70 years
✓. BMI = 25-40 kg/m2;
✓. HbA1c = 7.5-10.0%;
✓. Type 2 Diabetics who are drug naïve or treated with metformin, sulfonylureas, SGLT-2 inhibitors or any combination thereof.
✓. Subjects must be on a stable dose of antidiabetic medications for at least 3 months prior to study.
✓. Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
✓. Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period
Exclusion criteria
✕. Subjects with a personal or family history of pancreatic neuroendocrine tumors or multiple endocrine neoplasia, due to the potential increased of pancreatic alpha cell carcinogenicity associated with glucagon receptor antagonists.
✕. Subjects with a contraindication to MRI including artificial heart valves or pacemakers
What they're measuring
1
Glycated Hemoglobin (HbA1c)
Timeframe: Baseline to 13 weeks
2
Fasting Plasma glucose (FPG)
Timeframe: Baseline to 13 weeks
3
Plasma glucose (PG)
Timeframe: Baseline to 13 weeks
4
Hepatic insulin sensitivity
Timeframe: Baseline to 13 weeks
5
Whole body glucose disposal
Timeframe: Baseline to 13 weeks
6
Plasma Free Fatty Acids (FFA)
Timeframe: Baseline to 13 weeks
7
Muscle Insulin sensitivity
Timeframe: Baseline to 13 weeks
Trial details
NCT IDNCT05093517
SponsorThe University of Texas Health Science Center at San Antonio
✕. Patients with a known sensitivity to humanized antibodies
✕. Subjects treated with GLP-1 RAs or insulin are excluded.
✕. Subjects treated with a non-antidiabetic medication that may impact insulin sensitivity, such as systemic steroids, or lipase inhibitors (orlistat, Alli or Xenical)