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SGLT2 Inhibitor

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

N/A
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
Must not have
Receiving therapy with a sodium glucose co-transporter 2 (SGLT2) inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
Hepatic impairment (aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been on SGLT2 inhibitor medication or had a bad reaction to it within the last 8 weeks.
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My liver tests are significantly higher than normal.
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I am currently taking SGLT2 inhibitor medication.
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I have been diagnosed with type 1 diabetes.
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I have had an organ transplant.
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I have polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in serum klotho levels at 12 week
Change in serum klotho levels at 6 weeks
Secondary study objectives
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%
Sinusitis
1%
Syncope
1%
Carpal tunnel syndrome
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 4
~17870

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,080 Previous Clinical Trials
1,056,285 Total Patients Enrolled
11 Trials studying Diabetes
20,079 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 — N/A
Diabetes Research Study Groups: Group 1
Diabetes Clinical Trial 2023: Dapagliflozin Highlights & Side Effects. Trial Name: NCT05033054 — N/A
Dapagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05033054 — N/A
~0 spots leftby Dec 2024
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