Your session is about to expire
← Back to Search
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 belowSelect...
My kidney function is moderately to severely reduced.
Select...
I am between 18 and 80 years old.
Select...
I have been diagnosed with type 2 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
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 • NCT032143804%
Nasopharyngitis
2%
Upper respiratory tract infection
1%
Diarrhoea
1%
Gastritis
1%
Empyema
1%
Diabetic ulcer
100%
80%
60%
40%
20%
0%
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)
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
1,056 Previous Clinical Trials
1,054,934 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have high blood pressure or I'm on medication to control my normal blood pressure.I can keep my vitamin D and calcium supplement doses the same for 6 months after starting the trial.I haven't had treatments like chemotherapy or immunotherapy for kidney disease in the last 6 months.I have been on SGLT2 inhibitor medication or had a bad reaction to it within the last 8 weeks.My kidney function is moderately to severely reduced.Your body mass index is higher than 45.My liver tests are significantly higher than normal.This criterion does not provide clear information. If you can provide more context, I can assist in rewriting it for better understanding.You have a history of having too much calcium in your blood for a long time.Your urine test shows a high level of protein compared to creatinine.I am not pregnant, breastfeeding, and willing to use birth control if I can have children.I am currently being treated for cancer, except for basal or squamous cell skin cancer that has been successfully treated.I am currently taking SGLT2 inhibitor medication.You are currently on the waiting list for a kidney transplant.I have been diagnosed with type 1 diabetes.My gender does not affect my eligibility.I have had an organ transplant.My doctor thinks I have more than 2 years to live, not counting kidney or heart disease.I am between 18 and 80 years old.I have been diagnosed with type 2 diabetes.I have polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger