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SGLT2 Inhibitor

SGLT2 Inhibitors for Type 2 Diabetes with CKD Stage 3b-4

Phase 1
Recruiting
Led By Robert Toto, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Estimated glomerular filtration rate (GFR) (CKD Epi equation) of 15-44 ml/min/1.73 m2 (Stages 3b-4 CKD)
18-80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Awards & highlights

Study Summary

This trial is designed to see if Effervescent calcium magnesium citrate (EffCaMgCitrate) and dapagliflozin have an effect on surrogate markers of kidney and cardiovascular health in patients with stage 3b-4 Chronic Kidney Disease (CKD). 30 patients will be recruited and randomly assigned to one of three groups: placebo, CaMgcitrate 480mg Mg, or dapagliflozin 10mg. The trial will last 24 weeks.

Who is the study for?
This trial is for adults aged 18-80 with type 2 diabetes and moderate to severe chronic kidney disease (stages 3b-4). Participants should have a history of hypertension, maintain stable doses of vitamin D and calcium supplements, and not be on any SGLT2 inhibitors prior to the study. Exclusions include those with recent immunotherapy or organ transplants, severe liver issues, BMI over 45, active malignancies (except certain skin cancers), or women who are pregnant/breastfeeding and not using contraception.Check my eligibility
What is being tested?
The trial is observing how SGLT2 inhibitors affect heart and kidney health markers in patients with stage 3b-4 chronic kidney disease over a period of 12 weeks. It involves three clinic visits and weekly phone calls. The main focus is on changes in serum klotho levels—a protein linked to aging—measured by specific lab techniques.See study design
What are the potential side effects?
While the side effects aren't detailed here, common ones associated with SGLT2 inhibitors can include urinary tract infections, yeast infections due to increased sugar in urine, low blood pressure, diabetic ketoacidosis (a serious complication where the body produces excess blood acids), dehydration/thirst due to increased urination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is moderately to severely reduced.
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I am between 18 and 80 years old.
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I have been diagnosed with type 2 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in serum klotho levels at 12 week
Change in serum klotho levels at 6 weeks
Secondary outcome measures
Change in serum magnesium levels at 12 weeks
Change in serum magnesium levels at 6 weeks

Side effects data

From 2019 Phase 3 trial • 933 Patients • NCT03214380
6%
Diarrhoea
5%
Nasopharyngitis
1%
Syncope
1%
Carpal tunnel syndrome
1%
Sinusitis
1%
Lumbar radiculopathy
1%
Acute myocardial infarction
100%
80%
60%
40%
20%
0%
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: Group 1Experimental Treatment1 Intervention
Group 1: take prescribed SGLT2i after baseline visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SGLT2 inhibitor
2019
Completed Phase 3
~17850

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,747 Total Patients Enrolled
10 Trials studying Diabetes
20,029 Patients Enrolled for Diabetes
Robert Toto, MDPrincipal InvestigatorUT Southwestern Medical Center
1 Previous Clinical Trials
18,268 Total Patients Enrolled
1 Trials studying Diabetes
18,268 Patients Enrolled for Diabetes

Media Library

Dapagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05033054 — Phase 1
Diabetes Research Study Groups: Group 1
Diabetes Clinical Trial 2023: Dapagliflozin Highlights & Side Effects. Trial Name: NCT05033054 — Phase 1
Dapagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05033054 — Phase 1

Frequently Asked Questions

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

What is the current recruitment capacity for this research endeavor?

"Currently, this study is not taking on any new recruits. It was first published September 1st 2022 and the most recent update occurred May 26th 2022. If you are searching for other trials related to chronic kidney disease (CKD), 662 studies are in need of participants; 63 clinicals trials require individuals seeking treatment with EffCaMgCitrate 480 mg."

Answered by AI

Would you consider this a groundbreaking investigation?

"As of now, 63 active clinical trials for EffCaMgCitrate 480 mg are underway in 235 cities and 50 different countries. In 2014 AstraZeneca launched the first trial involving a total of 700 patients; since then, 174 studies have been concluded successfully."

Answered by AI

Are there still openings available for participants in this clinical trial?

"According to the clinicaltrials.gov website, this clinical trial is not currently enrolling participants. It was initially posted on September 1st 2022 and has since been edited on May 26th 2022; however, there are still 725 other medical trials that are open for enrollment at the present time."

Answered by AI

Who qualifies for participation in this research trial?

"Prospective applicants must have a diagnosis of chronic kidney disease (CKD) and be between 18 to 80 years old in order to join this clinical trial. Altogether, 36 individuals will be included."

Answered by AI

Has EffCaMgCitrate 480 mg been granted permission by the FDA?

"With limited data on both safety and efficacy, EffCaMgCitrate 480 mg was given a score of 1."

Answered by AI

Is there an age-restriction for participants of this experiment?

"As outlined in the criteria for entry, individuals must be 18 years or older and not past their 80th birthday to join this trial."

Answered by AI

What afflictions has EffCaMgCitrate 480 mg been proven to alleviate?

"EffCaMgCitrate 480 mg is useful for patients trying to manage their pharmaceutical usage, diet, and exercise habits."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of SGLT2i on Cardiovascular Biomarkers in Patients With Type 2 Diabetes and CKD Stage 3b-4
Robert Toto 2022. "Effect of SGLT2i on Cardiovascular Biomarkers in Patients With Type 2 Diabetes and CKD Stage 3b-4". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05033054.
All > Type 2 Diabetes
~8 spots leftby Dec 2024
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