What side effects are associated with this type of intervention?

SGLT2 inhibitors, such as Canagliflozin, Dapagliflozin, and Empagliflozin, are commonly used to treat Diabetic Kidney Disease by reducing glucose reabsorption and increasing glucose excretion. Known side effects of these medications include an increased risk of urinary tract infections, genital infections, and dehydration due to their diuretic effect. Canagliflozin has also been associated with a higher risk of below-the-knee amputations, although this risk has not been observed consistently across all SGLT2 inhibitors. Other potential side effects include mild hypoglycemia, particularly when used in combination with other glucose-lowering agents.

What prior FDA approvals exist?

The FDA has approved several SGLT2 inhibitors for the treatment of Diabetic Kidney Disease (DKD), including Canagliflozin, Empagliflozin, and Dapagliflozin. These medications work by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which reduces glucose reabsorption and increases glucose excretion. Clinical trials have demonstrated that these drugs not only improve glycemic control but also provide cardiovascular and renal benefits, making them a valuable option for patients with DKD.

What other types of research exist?

Promising alternatives to Canagliflozin for DKD patients include other SGLT2 inhibitors such as Dapagliflozin and Empagliflozin, which have shown renal protective effects. Additionally, GLP-1 receptor agonists like Liraglutide and Semaglutide are emerging as effective options due to their benefits on glycemic control and potential renal protection. Both drug classes have been approved for use in CKD and diabetes management.

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SGLT2 Inhibitor

Canagliflozin for Diabetic Kidney Disease

Phase 4

Recruiting

Led By Markus Bitzer, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month follow-up

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing Canagliflozin, a medication that helps remove sugar from the body through urine, on adults with Type 2 diabetes and early kidney disease. The goal is to see if it can protect their kidney function by lowering blood sugar levels.

Who is the study for?

This trial is for adults aged 18-80 with Type 2 diabetes diagnosed at least 3 years ago, who may also have kidney disease. Participants must have two functioning kidneys confirmed by ultrasound and be willing to undergo multiple tests including MRIs, biopsies, and provide blood, urine, and optional stool samples.

What is being tested?

The study is testing the effects of an FDA-approved SGLT2 inhibitor drug called Canagliflozin (INVOKANA) on kidney function in people with Type 2 diabetes. It's an open-label trial where participants know they're taking Canagliflozin daily for six months while undergoing health assessments.

What are the potential side effects?

Possible side effects of Canagliflozin include dehydration leading to low blood pressure, yeast infections due to sugar in urine attracting fungi, increased urination as the body tries to remove excess glucose through pee, and a rare risk of diabetic ketoacidosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Glomerular basement membrane (GBM) width and mesangial expansion

Secondary study objectives

Kidney Transcript Changes

Side effects data

From 2019 Phase 3 trial • 933 Patients • NCT03214380

Nasopharyngitis

Upper respiratory tract infection

Diarrhoea

Gastritis

Empyema

Diabetic ulcer

100%

80%

60%

40%

20%

Study treatment Arm

Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment

Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)

LY900014

Insulin Lispro (Humalog) Lead-In

Insulin Lispro (Humalog)

LY900014 (MEE)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SGLT2i ArmExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SGLT2 inhibitor

2019

Completed Phase 4

~17870

Do I qualify?Apply below to find out

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

The most common treatments for Diabetic Kidney Disease (DKD) include ACE inhibitors, ARBs, and SGLT2 inhibitors. ACE inhibitors and ARBs work by dilating blood vessels and reducing blood pressure, which helps to decrease the progression of kidney damage. SGLT2 inhibitors, such as Canagliflozin, reduce glucose reabsorption in the kidneys, leading to increased glucose excretion in the urine. This not only helps in controlling blood sugar levels but also has protective effects on the kidneys by reducing hyperfiltration and lowering intraglomerular pressure. These mechanisms are crucial for DKD patients as they help to slow the progression of kidney disease and reduce the risk of end-stage kidney disease.

Sodium Glucose Cotransporter-2 Inhibition and Cardiorenal Protection: JACC Review Topic of the Week.Effect of Canagliflozin on Urinary Albumin Excretion in Japanese Patients with Type 2 Diabetes Mellitus and Microalbuminuria: A Pilot Study.