What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, particularly SGLT2 inhibitors and GLP-1 receptor agonists, have specific side effects. SGLT2 inhibitors, such as canagliflozin, can cause urinary tract infections, genital mycotic infections, and a potential risk of lower limb amputations, along with an initial decrease in eGFR that usually recovers. GLP-1 receptor agonists may lead to gastrointestinal issues like nausea, vomiting, and diarrhea, and there is a potential risk of pancreatitis. Both drug classes have demonstrated benefits in reducing cardiovascular events and improving renal outcomes.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of Type 2 Diabetes that also address complications like Diabetic Kidney Disease. Notably, GLP-1 receptor agonists such as liraglutide, semaglutide, and dulaglutide have demonstrated favorable cardiovascular and kidney outcomes. Additionally, SGLT2 inhibitors like empagliflozin, canagliflozin, and dapagliflozin have shown benefits in reducing cardiovascular events and improving kidney function. These treatments are significant as they target the underlying pathophysiology of diabetes-related complications, including kidney disease.

What other types of research exist?

Promising alternatives to INV-202 for Type 2 Diabetes patients with Diabetic Kidney Disease include: 1) Canagliflozin, which has shown potential in reducing urinary albumin excretion and may offer a novel therapeutic option. 2) Dapagliflozin, which has demonstrated a reduction in the urine albumin-to-creatinine ratio and has been approved for the treatment of chronic kidney disease in adults with and without diabetes. 3) Glucagon-like peptide-1 receptor agonists (GLP1-RAs), which have shown cardiovascular and renal benefits in clinical trials.

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INV 202 for Diabetic Kidney Disease

Verified Trial

Phase 2

Waitlist Available

Research Sponsored by Inversago Pharma Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have you been diagnosed with Diabetic Kidney Disease due to Type 1 Diabetes or Type 2 Diabetes?

Is your hemoglobin A1C (HbA1c) less than 9.5%?

Timeline

Screening 4 weeks

Treatment Varies

Follow Up 16 weeks

Summary

This trial tests a new drug called INV-202 in adults with Diabetic Kidney Disease caused by Type 1 or Type 2 diabetes. The goal is to see if the drug is effective, safe, and well-tolerated, and how it behaves in the body.

Who is the study for?

This trial is for adults with Diabetic Kidney Disease linked to Type 1 or Type 2 diabetes, who have managed their diabetes stably for at least 4 months and have an HbA1c below 9.5%. It's not for those with recent drug abuse, thyroid issues, significant psychiatric disorders, other kidney diseases (except hypertension), or those using cannabis products recently.

What is being tested?

The study tests INV-202 against a placebo in treating Diabetic Kidney Disease. Participants will be randomly assigned to receive either the investigational drug INV-202 or a placebo to evaluate its effectiveness and safety.

What are the potential side effects?

While specific side effects of INV-202 are not listed here, common ones may include reactions at the injection site, nausea, fatigue, and potential allergic responses. Safety and tolerability are key aspects being monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Diabetic Kidney Disease.

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I have been on a stable diabetes medication regimen for at least 4 months.

Timeline

Screening ~ 4 weeks1 visit

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 4 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 4 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in UACR from baseline to W16

Secondary study objectives

Change in eGFR using cystatin C and the CKD-EPI formula from baseline to W16

Change in eGFR using serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula from baseline to W16

Change in urine protein to creatinine ratio (UPCR) from baseline to W16

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: INV-202 25 mgExperimental Treatment1 Intervention

INV-202 25 mg Arm

Group II: INV 202 10 mgExperimental Treatment1 Intervention

INV-202 10 mg Arm

Group III: PlaceboPlacebo Group1 Intervention

Placebo Arm

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INV-202

2022

Completed Phase 2

~310

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes (T2DM) include incretin-based therapies, SGLT2 inhibitors, and insulin. Incretin-based therapies, such as GLP-1 receptor agonists, enhance insulin secretion and inhibit glucagon release, aiding in blood glucose regulation. SGLT2 inhibitors, like canagliflozin, lower blood glucose by preventing its reabsorption in the kidneys, leading to glucose excretion in urine. Insulin therapy supplements or replaces the body's insulin to control blood glucose levels. These treatments are vital for T2DM patients as they address different aspects of the disease's pathophysiology, offering comprehensive management and potentially reducing complications like diabetic kidney disease.

[News in diabetology 2021].The Mystery of Diabetic Cardiomyopathy: From Early Concepts and Underlying Mechanisms to Novel Therapeutic Possibilities.Pharmacologic Approaches to Glycemic Treatment of Type 2 Diabetes: Synopsis of the 2020 American Diabetes Association's Standards of Medical Care in Diabetes Clinical Guideline.