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New treatment option for Type 2 Diabetes
Official title Mechanism of SGLT2 Inhibition in the Kidney
ClinicalTrials.gov ID: NCT06291155
What this study is testing
What is SGLT2 inhibitor?
SGLT2 inhibitor is an investigational medicine, given as an once-daily, being studied as a potential treatment for type 2 diabetes.
Also referred to as Canagliflozin, Invokana.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this open-label, non-randomized clinical trial is to determine what effects, if any, an FDA-approved drug class known as SGLT2 inhibitors (Canagliflozin or INVOKANA) has any protective effects on kidney function in Type 2 diabetes. We are looking for participants 18-80 years of age, who have had a clinical diagnosis of Type 2 diabetes for ≥ 3 years.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
- Estimated GFR \>45 and \< 90 ml/min/1.73m2 as determined from the CKD-EPI equation using serum creatinine (Levey et al., 2009)
- A screening urinary albumin-to-creatinine ratio \<3000 mg/g.
You likely can't join if
- Clinically significant disorders of the liver [cirrhosis, portal hypertension, hepatitis, increased bilirubin (≥1.5 mg/dl), active or uncontrolled...
- Prior and ongoing treatment with SGLT2 inhibitors
- Renovascular or malignant hypertension; uncontrolled hypertension (systolic blood pressure ≥150 or diastolic ≥90 mm Hg)
- Hematuria of unknown etiology.
- Prior to entry into the study, any participant with hematuria should be evaluated, the etiology established and documented, and treatment rendered as...
- Chronic debilitating disorders with or without treatment (e.g., systemic lupus erythematosus [SLE], cancer, amyloidosis, and chronic infection) that...
See the full eligibility criteria
- 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.
- Estimated GFR \>45 and \< 90 ml/min/1.73m2 as determined from the CKD-EPI equation using serum creatinine (Levey et al., 2009)
- A screening urinary albumin-to-creatinine ratio \<3000 mg/g.
- Willingness to participate after receiving a thorough explanation of the study.
- Participants receiving a RAAS inhibitor must have been receiving the drug at maximum tolerable dose for at least 3 months prior to the study baseline examination.
- Participants receiving a GLP-1 receptor agonist must have been receiving the drug for at least 3 months prior to the study baseline examination.
- Participants must meet the current clinical guidelines for prescribing SGLT2 inhibitors, to maintain FDA-approved standards
- Clinically significant disorders of the liver [cirrhosis, portal hypertension, hepatitis, increased bilirubin (≥1.5 mg/dl), active or uncontrolled cardiovascular disease, symptomatic peripheral vascular disease, (i.e...
- Prior and ongoing treatment with SGLT2 inhibitors
- Renovascular or malignant hypertension; uncontrolled hypertension (systolic blood pressure ≥150 or diastolic ≥90 mm Hg)
- Hematuria of unknown etiology.
- Prior to entry into the study, any participant with hematuria should be evaluated, the etiology established and documented, and treatment rendered as appropriate.
- Chronic debilitating disorders with or without treatment (e.g., systemic lupus erythematosus [SLE], cancer, amyloidosis, and chronic infection) that would interfere with the assessment of kidney function or that might...
- Currently receiving a drug regimen that includes steroids, immunosuppressants, or investigational new drugs not associated with this trial.
- Pregnancy.
- SGLT2 inhibitors are not recommended during the second or third trimester of pregnancy. Moreover, we do not wish to expose pregnant women to conscious sedation that is used during the kidney biopsies.. Women of...
- Known hypersensitivity to canagliflozin or iodine.
- Bleeding disorders or requirements for anticoagulation or platelet inhibitors which cannot be safely interrupted since kidney biopsies cannot be performed safely in these individuals.
- Massive obesity with body mass index ≥45 kg/m².
- Kidney biopsies are more technically difficult with massive obesity.
- Allergy to iodine-containing contrast material or shellfish.
- Non-diabetic kidney disease - based on clinical history or kidney biopsy examination.
- History of osteoporotic fracture.
- History of lower-limb amputation irrespective of etiology
- Conditions likely to interfere with informed consent or compliance with the protocol.
- Known solitary kidney
- Size of one or both kidneys on ultrasound \ 2 cm discrepancy between left and right kidney sizes based on largest longitudinal diameter
- Current use of UGT enzyme inducters, lithium, and digoxin
- Blood urea nitrogen (BUN) \> 80 gm/dL
- INR \> 1.4 (a)
- PTT \> 35 seconds (a)
- Platelet count \< 100,000 uL (a)
- Hemoglobin (Hgb) \< 10 mg/dL (a)
- Hydronephrosis or other important renal ultrasound findings such as significant stone disease
- Inclusion possible after this has been obtained within range
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.