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SGLT2 Inhibitor

SGLT2i Arm 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

Study Summary

"This trial is looking at the effects of a drug called Canagliflozin on kidney function in people with Type 2 diabetes. They are looking for participants aged 18-80 who have

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glomerular basement membrane (GBM) width and mesangial expansion

Secondary outcome measures

Kidney Transcript Changes

Side effects data

From 2019 Phase 3 trial • 933 Patients • NCT03214380

Diarrhoea

Nasopharyngitis

Syncope

Carpal tunnel syndrome

Sinusitis

Lumbar radiculopathy

Acute myocardial infarction

100%

80%

60%

40%

20%

Study treatment Arm

Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)

Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment

LY900014

Insulin Lispro (Humalog) Lead-In

Insulin Lispro (Humalog)

LY900014 (MEE)

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 3

~17850

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,378,118 Total Patients Enrolled

University of Colorado, DenverOTHER

1,738 Previous Clinical Trials

2,149,506 Total Patients Enrolled

Renal Pre-Competitive Consortium (RPC3)UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this research study?

"To qualify for participation in this medical study, individuals must have a diagnosis of type 2 diabetes and be aged between 18 and 80 years. Approximately 20 participants are sought for enrollment in the trial."

Answered by AI

How many individuals are enrolled as participants in this ongoing medical study?

"Indeed, the information on clinicaltrials.gov shows that this medical research endeavor is actively seeking participants. The trial was uploaded on January 1st, 2024 and last revised on February 26th, 2024. It aims to enroll a total of twenty individuals from one designated site."

Answered by AI

Are patients currently eligible to participate in this ongoing research study?

"As per the details available on clinicaltrials.gov, this investigation is presently seeking eligible participants. It was initially uploaded on January 1st, 2024 and last revised on February 26th, 2024."

Answered by AI

Is the clinical trial open to individuals younger than 35 years old?

"Participants aged between 18 and 80 are eligible for enrollment in this clinical trial. It is noteworthy that there exist a total of 83 trials targeting individuals under the age of 18 and an additional 1168 studies focusing on those above 65 years old."

Answered by AI