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New treatment option for Type 2 Diabetes
Official title DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study, a Randomized, Placebo-controlled, Cross-over Study With Ertugliflozin in People With Type 2 Diabetes
ClinicalTrials.gov ID: NCT06983054
What this study is testing
What is ertugliflozine?
ertugliflozine is an investigational medicine, being studied as a potential treatment for type 2 diabetes.
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
- SGLT2 inhibitors have demonstrated to mitigate cardiorenal risk in people with type 2 diabetes and are likely to play an increasingly large role in the treatment of patients with diabetes, chronic kidney disease and hypertension. Yet the underlying mechanisms of its protective effects are incompletely understood and the salutary effect may be altered by dietary factors such as sodium intake.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, 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 85
You may be able to join if
- Adults with previously diagnosed T2DM according to American Diabetes Association (ADA) criteria
- HbA1c 6.5-10%
- Age 18 - 85 years of age
- Overweight or obese with BMI: \>25 kg/m2
- We will make every effort to enrol participants of all races/ethnicities."
You likely can't join if
- History of unstable or rapidly progressing renal disease NL80772.029.22 / DC2022ERTU DESIGN Protocol DESIGN, Study NO. 2022.0737 Version...
- Estimated GFR \ 90 mL/min/1.73m2 determined by CKD-EPI
- UACR \> 30 mg/mmol
- Current/chronic use of the following medication: SGLT2 inhibitors, TZD, GLP-1RA, glucocorticoids, immune suppressants, antimicrobial agents...
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic...
- History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to the...
See the full eligibility criteria
- Adults with previously diagnosed T2DM according to American Diabetes Association (ADA) criteria
- HbA1c 6.5-10%
- Age 18 - 85 years of age
- Overweight or obese with BMI: \>25 kg/m2
- We will make every effort to enrol participants of all races/ethnicities."
- Both sexes (females must be post-menopausal; no menses \>1 year; in case of doubt, Follicle-Stimulating Hormone (FSH) will be determined with cut-off defined as \>31 U/L)
- Ability to provide signed and dated, written informed consent prior to any study procedures
- Estimated GFR 60-90 ml/min/1.73m2 by CKD-EPI matching the eGFR range of most participants in VERTIS-CV
- Sodium intake at baseline \< 200 mmol/day
- UACR \< 30 mg/mmol
- All participants need to be on a stable dose of diabetes medication, including Metformin, SU, DPP4-inhibitors, or insulin.
- Participants suffering from hypertension need to be on a stable dose of RAS inhibitors. In case RAS inhibition is not tolerated, the participant should to be on a stable dose of other antihypertensive treatment.
- History of unstable or rapidly progressing renal disease NL80772.029.22 / DC2022ERTU DESIGN Protocol DESIGN, Study NO. 2022.0737 Version 5.0dd22-02-2024 14 of 45
- Estimated GFR \ 90 mL/min/1.73m2 determined by CKD-EPI
- UACR \> 30 mg/mmol
- Current/chronic use of the following medication: SGLT2 inhibitors, TZD, GLP-1RA, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics Participants should be on a stable dose of antipsychotics...
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, headache or back ache). However, no...
- History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to the Screening visit.
- Current urinary tract infection and active nephritis
- Recent (\<6 months) history of cardiovascular disease, including:
- Acute coronary syndrome
- Chronic heart failure (New York Heart Association grade II-IV)
- Stroke or transient ischemic neurologic disorder
- Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN
- Active malignancy. History of malignancy is allowed unless the participant still has active treatment other than hormonal therapy. History of or actual severe mental disease
- Substance abuse (alcohol: defined as \>4 units/day)
- Allergy to any of the agents used in the study
- Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel...
- Inability to understand the study protocol or give informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Amsterdam, Netherlands. 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.