REMD-477 for Type 2 Diabetes

Texas Diabetes Institute, San Antonio, TX
Type 2 Diabetes+2 More ConditionsREMD-477 - Drug
Eligibility
18 - 70
All Sexes

Study Summary

This trial will help to understand how glucagon affects diabetes.

Eligible Conditions
  • Type 2 Diabetes
  • Insulin Sensitivity
  • Impaired Glucose Tolerance

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase < 1

Study Objectives

7 Primary · 0 Secondary · Reporting Duration: Baseline to 13 weeks

Baseline to 13 weeks
Fasting Plasma glucose (FPG)
Glycated Hemoglobin (HbA1c)
Hepatic insulin sensitivity
Muscle Insulin sensitivity
Plasma Free Fatty Acids (FFA)
Plasma glucose (PG)
Whole body glucose disposal

Trial Safety

Phase-Based Safety

1 of 3

Side Effects for

Part B - 35 mg REMD-477
12%Nausea
8%Hypoglycaemia
8%Headache
8%Dizziness
8%Vomiting
8%Upper respiratory tract infection
4%Diabetic retinopathy
4%Diarrhoea
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03117998) in the Part B - 35 mg REMD-477 ARM group. Side effects include: Nausea with 12%, Hypoglycaemia with 8%, Headache with 8%, Dizziness with 8%, Vomiting with 8%.

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2 Treatment Groups

Glucagon Receptor Agonist (GRA) REMD-477 group
1 of 2
Placebo group
1 of 2

Experimental Treatment

Non-Treatment Group

24 Total Participants · 2 Treatment Groups

Primary Treatment: REMD-477 · Has Placebo Group · Phase < 1

Glucagon Receptor Agonist (GRA) REMD-477 group
Drug
Experimental Group · 1 Intervention: REMD-477 · Intervention Types: Drug
Placebo group
Drug
PlaceboComparator Group · 1 Intervention: Placebo Subcutaneous injection · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glucagon
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 13 weeks

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
418 Previous Clinical Trials
80,992 Total Patients Enrolled
Ralph DeFronzo, MDPrincipal InvestigatorUniversity of Texas Health San Antonio
8 Previous Clinical Trials
914 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Texas Diabetes Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

What is the usual application of REMD-477?

"REMD-477 has been demonstrated to be effective for managing [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) mellitus, diabetes, and hypoglycemia." - Anonymous Online Contributor

Unverified Answer

Am I eligible to participate in this trial?

"This medical trial seeks 24 participants aged between 18 and 70 with type 2 diabetes mellitus who meet the following criteria: Drug free or taking metformin, sulfonylureas, SGLT-2 inhibitors; BMI of 25-40 kg/m2; Non-lactating postmenopausal females two years past menopause or using approved contraceptive methods; Hysterectomy patients eligible. All female participants must have a negative pregnancy test throughout the duration of the study." - Anonymous Online Contributor

Unverified Answer

Is this test still recruiting participants?

"The information found on clinicaltrials.gov reveals this medical trial is currently seeking participants. The registration date was November 10th 2021, with the most recent update being issued December 22nd 2021." - Anonymous Online Contributor

Unverified Answer

What is the aggregate number of participants involved in this trial?

"That is correct. According to the information available on clinicaltrials.gov, this medical trial was first posted on November 10th 2021 and has been actively searching for candidates since then. In total, 24 volunteers are needed from one site for this experiment." - Anonymous Online Contributor

Unverified Answer

Does this study accept participants of a certain age range, such as those under 35?

"This trial is researching participants over the age of 18 and below 70 years old." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.