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SGLT2 Inhibitor

Canagliflozin for Diabetic Kidney Disease

Phase 2
Recruiting
Led By Petter MPetter Bjornstad, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-80 years. The lower age limit was set so renal function test results would not reflect changes associated with growth.
Diagnosis of type 2 diabetes for ≥ 3 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is studying how well canagliflozin works to protect the kidneys in adults with type 2 diabetes.

Who is the study for?
Adults aged 18-80 with type 2 diabetes for at least 3 years, kidney function within a specific range (GFR >45 and <90), not on SGLT2 inhibitors or able to do a wash-out. Must not have significant liver, heart, lung diseases, bleeding disorders, massive obesity (BMI ≥45), known allergies to trial drugs or iodine, non-diabetic kidney disease, uncontrolled hypertension or be pregnant.Check my eligibility
What is being tested?
The study is examining how canagliflozin protects against diabetic kidney disease in adults with type 2 diabetes using advanced kidney imaging and tests. It involves taking the oral drug canagliflozin and undergoing detailed assessments of how it affects the kidneys.See study design
What are the potential side effects?
Canagliflozin may cause side effects like increased urination leading to dehydration and low blood pressure; yeast infections due to sugar in urine; higher risk of bone fractures; potential increase in cholesterol levels; and rare but serious genital infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I have been diagnosed with type 2 diabetes for 3 years or more.
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I have been on a GLP-1 receptor agonist medication for at least 3 months.
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I have been taking the highest dose I can tolerate of a RAAS inhibitor for at least 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months 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
Kidney Transcript Changes
Secondary outcome measures
Cortical R2
Glomerular Filtration Rate (GFR)
Medullary R2
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment2 Interventions
Participants who will receive 100 mg of canagliflozin daily for six (6) months in addition to standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
canagliflozin
2016
N/A
~10
Aminohippurate Sodium Inj 20%
2018
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,338 Total Patients Enrolled
Boston Medical CenterOTHER
382 Previous Clinical Trials
869,419 Total Patients Enrolled
University of MichiganOTHER
1,787 Previous Clinical Trials
6,365,494 Total Patients Enrolled

Media Library

canagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05507892 — Phase 2
Diabetic Kidney Disease Research Study Groups: Treatment
Diabetic Kidney Disease Clinical Trial 2023: canagliflozin Highlights & Side Effects. Trial Name: NCT05507892 — Phase 2
canagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05507892 — Phase 2
Diabetic Kidney Disease Patient Testimony for trial: Trial Name: NCT05507892 — Phase 2

Frequently Asked Questions

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

What primary goal does this experiment hope to accomplish?

"The primary objective of this six-month study is to observe changes in Glomerular basement membrane (GBM) width and mesangial expansion. Medullary R2, Renal Perfusion, and Glomerular Filtration Rate (GFR) will also be monitored as secondary outcomes."

Answered by AI

How many people fit the bill for participating in this trial?

"Yes, the trial is ongoing and patients are being enrolled at 4 locations. The clinicaltrials.gov website shows that the trial was first posted on October 10th, 2020, and was last updated on October 31st, 2020. The goal is to enroll 40 patients in total."

Answered by AI

What have been the most serious reported side effects of canagliflozin?

"While there is some evidence to support canagliflozin's safety, it is only from early phase clinical trials. More research is needed to support its efficacy."

Answered by AI

Does the age limit for this clinical trial extend to those who are younger than 25 years old?

"This particular clinical trial is only open to adults aged 18-80. However, there are 66 other trials for minors and 770 trials for seniors."

Answered by AI

Are we currently recruiting volunteers for this research project?

"The most recent update on clinicaltrials.gov was on 10/31/2022, which confirms that the study is still recruiting patients. This particular trial was posted on 10/10/2022 and is looking for 40 individuals total from 4 different locations."

Answered by AI

Who else is applying?

What state do they live in?
California
Michigan
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am type 1 diabetic.
PatientReceived 1 prior treatment
~6 spots leftby Jul 2024