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Type 2 DiabetesEarly Phase 1NCT05093517

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

A Early Phase 1 study testing REMD-477 in people with Type 2 Diabetes and Glucose Tolerance Impaired, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
REMD-477
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4 participants
Where
1 siteUnited States
Study dates
10 Nov 2021to 16 Mar 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • 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)
  • Hematocrit < 34 vol%
Show all 17Show fewer
  • Serum creatinine > 1.8 mg/dl
  • AST (SGOT) > 2 times upper limit of normal
  • ALT (SGPT) > 2 times upper limit of normal
  • Any major organ system disease as identified by medical history, physical exam, and screening blood tests, EKG
  • Subjects who cannot give written, voluntary consent
  • Subjects with a major psychiatric disturbance
  • Only subjects whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.
  • Patients must not have type 1 diabetes
  • Patients must not have a fasting plasma glucose of greater than 270 mg/dl or HbA1c > 10.0%
  • Patients must not have received a thiazolidinedione, GLP-1 agonist, or insulin for more than one week during the year prior to randomization
  • Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 2; more than non-specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas Diabetes Institute

    San Antonio, Texas, 78207

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
REMD-477, Placebo Subcutaneous injection
Keywords
Fasting plasma glucagon, Glucagon receptor antagonist
Medical subject headings
Diabetes Mellitus, Type 2, Glucose Intolerance, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REMD-477Drug

    A biologic glucagon receptor agonist to which randomized subjects are assigned 2:1

  • Placebo Subcutaneous injectionDrug

    Also called Placebo

    Placebo for REMD-477 to which subjects will be randomized 1:2.

Study groups in NCT05093517
Study groupRoleWhat they receive
Glucagon Receptor Agonist (GRA) REMD-477 groupExperimentalParticipants are assigned to a 12 week treatment of REMD-477
Receives: Drug: REMD-477
Placebo groupPlacebo comparatorParticipants are assigned to a 12 week course of placebo for REMD-477
Receives: Drug: Placebo Subcutaneous injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycated Hemoglobin (HbA1c)

    Change in HbA1c measured at baseline and after intervention administration

    Measured: Baseline to 13 weeks

  2. Fasting Plasma glucose (FPG)

    Change in fasting plasma glucose measured at baseline and after intervention administration

    Measured: Baseline to 13 weeks

  3. Plasma glucose (PG)

    Change in plasma PG measured at baseline and after intervention administration using an oral glucose tolerance test (OGTT)

    Measured: Baseline to 13 weeks

  4. Hepatic insulin sensitivity

    Change in hepatic glucose production (HGP)

    Measured: Baseline to 13 weeks

  5. Whole body glucose disposal

    Change in whole body glucose disposal measured in mg/kg/min

    Measured: Baseline to 13 weeks

  6. Plasma Free Fatty Acids (FFA)

    Change in plasma free fatty acids

    Measured: Baseline to 13 weeks

  7. Muscle Insulin sensitivity

    Change in muscle insulin sensitivity measured by insulin-stimulated glucose uptake during low dose high dose insulin clamp.

    Measured: Baseline to 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2021
  2. Study start10 Nov 2021
  3. Primary completion16 Mar 2022
  4. Study completion16 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized 2-arm placebo controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05093517
Sponsor's protocol ID
HSC20210463H
Status last verified
Aug 2024
First submitted
14 Oct 2021
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Summary results will be published in ClinicalTrials.gov as required by law and research findings will be published in a peer reviewed scientific journal.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing REMD-477 in people with Type 2 Diabetes and Glucose Tolerance Impaired, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycated Hemoglobin (HbA1c) (time frame: Baseline to 13 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05093517.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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