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Effect of Novel Glucagon Receptor Antagonist REMD-477 on Glucose and Adipocyte Metabolism in T2DM | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

Effect of Novel Glucagon Receptor Antagonist REMD-477 on Glucose and Adipocyte Metabolism in T2DM

Effect of Novel Glucagon Receptor Antagonist REMD-477 on Glucose and Adipocyte Metabolism in Type 2 Diabetes Mellitus (T2DM)

NCT05093517•The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

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.

Detailed Description

Subjects with T2DM inadequately controlled on current medications will participate in a glucose tolerance test, euglycemic insulin clamp combined with 3-3H-glucose and 14-C glycerol infusion, adipose tissue biopsy, before and 12 weeks after treatment with REMD 477 or placebo.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Type 2 diabetic subjects, males/females;
•2. age = 18-70 years
•3. BMI = 25-40 kg/m2;
•4. HbA1c = 7.5-10.0%;
•5. Type 2 Diabetics who are drug naïve or treated with metformin, sulfonylureas, SGLT-2 inhibitors or any combination thereof.
•6. Subjects must be on a stable dose of antidiabetic medications for at least 3 months prior to study.
•7. Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
•8. 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

•1. 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.
•2. Subjects with a contraindication to MRI including artificial heart valves or pacemakers
•3. Patients with a known sensitivity to humanized antibodies
•4. Subjects treated with GLP-1 RAs or insulin are excluded.
•5. Subjects treated with a non-antidiabetic medication that may impact insulin sensitivity, such as systemic steroids, or lipase inhibitors (orlistat, Alli or Xenical)
•6. Hematocrit \< 34 vol%
•7. Serum creatinine \> 1.8 mg/dl
•8. AST (SGOT) \> 2 times upper limit of normal
•9. ALT (SGPT) \> 2 times upper limit of normal
•10. Any major organ system disease as identified by medical history, physical exam, and screening blood tests, EKG
+7 more criteria

Locations (1)

Texas Diabetes Institute

San Antonio, Texas, United States

Key Dates

Start Date

November 10, 2021

Primary Completion Date

March 16, 2022

Completion Date

March 16, 2022

Last Updated

August 9, 2024

Enrollment

ACTUAL participants

Conditions

Type 2 DiabetesGlucose Tolerance ImpairedInsulin Sensitivity

Interventions

REMD-477

DRUG

Placebo Subcutaneous injection

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Novel Glucagon Receptor Antagonist REMD-477 on Glucose and Adipocyte Metabolism in T2DM

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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