Renal Oxygenation, Oxygen Consumption and Hemodynamic Kinetics in Type 2 DIabetes: an Ertugliflozin Study. (ROCKIES)

This is an interventional prevention trial for Type 2 Diabetes Mellitus Read More

Group 1: T2DM patients

Inclusion criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Caucasian*; female or male aged ≥18 years and <80 years. Females must be post-menopausal (defined as no menses >1 year and follicle stimulating hormone (FSH) >31 U/L)*.
• Type 2 diabetes mellitus since at least 3 years with HbA1c ≥ 6.5% (≥57mmol/mol) and <10% (<94mmol/mol)
• An appropriate stable dose of metformin and/or sulfonylurea as glucose-lowering therapy for the last 12 weeks
• Maximum tolerated antihypertensive dose of an ARB for at least 6 weeks prior to randomization.
• eGFR 60-90 ml/min/1.73m²
• BMI 25-35 kg/m² * In order to increase homogeneity

Exclusion criteria

• Involvement in the planning and/or conduction of another study
• Participation in another clinical study with an investigational product during the last 3 months
• Diagnosis of type 1 diabetes mellitus
• CKD defined as eGFR<60 ml/min/1.73m² or albuminuria (defined as an UACR > 2.5 mg/mol).
• Cardiovascular disease event in the last 6 months prior to enrollment as assessed by the investigator, including: myocardial infarction, cardiac surgery or revascularization (CABG/PTCA), unstable angina, heart failure, transient ischemic attack (TIA) or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia.
• Current/chronic use of the following medication: insulin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, oral glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), immune suppressants, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs), diuretics, and monoamine oxidase inhibitors.
• Current urinary tract infection or active nephritis
• History of ketoacidosis
• History of allergy/hypersensitivity to any of the test agents.

Group 2: Age-matched and eGFR-matched non-diabetic controls Inclusion criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Caucasian*; female or male aged ≥18 years and <80 years. Females must be post-menopausal (defined as no menses >1 year and follicle stimulating hormone (FSH) >31 U/L)*.
• Normal glucose tolerance at screening as confirmed by OGTT
• Maximum tolerated antihypertensive dose of an ARB for at least 6 weeks prior to randomization in case of hypertension.
• BMI 25-35 kg/m2
• eGFR 60-90ml/min * In order to increase homogeneity

Exclusion criteria

• Involvement in the planning and/or conduction of another study
• Participation in another clinical study with an investigational product during the last 3 months
• CKD defined as eGFR<60ml/min or macro-albuminuria or proteinuria
• Cardiovascular disease event in the last 6 months prior to enrollment, as assessed by the investigator, including: myocardial infarction, cardiac surgery or revascularization (CABG/PTCA), unstable angina, heart failure, transient ischemic attack (TIA) or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia.
• Use of medication that may interfere with study endpoints non-steroidal anti-inflammatory drugs (NSAIDs), immune suppressants, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs), diuretics, and monoamine oxidase inhibitors.
• Current urinary tract infection and active nephritis
• Any other condition that prevents participation as judged by investigator.