The effects of SGLT2-inhibition in patients with type 2 diabetes and preserved kidney function on renal circulation, kidney function and hormones related to the circulation

The effects of SGLT2-inhibition in patients with type 2 diabetes and preserved kidney function on renal hemodynamics, kidney function and vasoactive hormones

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004303-12-DK

Enrollment

Registered

2020-06-23

Start date

2020-10-19

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Trade Name: Jardiance Pharmaceutical Form: Tablet INN or Proposed INN: Empagliflozin CAS Number: 864070-44-0 Other descriptive name: EMPAGLIFLOZIN Concentration unit: mg milligram(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Over 18 years of age • eGFR > 60 ml/min • Type 2 diabetes diagnosed at least 1 year before inclusion and in stable Medical antidiabetic treatment for at least 3 months • HbA1c 48 – 70 mmol/mol • Fertile women are to use safe contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • Type 1 diabetes • Alcohol or substance abuse • Pregnancy or breastfeeding • Anamnestic or clinical signs of heart- or liver failure • Active cancers, aside from skin cancers (spinocellular or basocellular carcinomas) • BMI > 35 • Allergies or unacceptable side effects to the experimental treatment or background treatment • If investigator finds the participant unfit to complete the trial

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine the effects of SGLT2-inhibition versus placebo on renal hemodynamics in patients with typ2 diabetes and preserved kidney function;Secondary Objective: To examine the effects of SGLT2-inhibition versus placebo on systemic hemodynamics, water- and sodium balance, tubular sodium transporters, vasoactive hormones and calcium-phosphate metabolism in patients with typ2 diabetes and preserved kidney function ;Primary end point(s): Renal Blood Flow ;Timepoint(s) of evaluation of this end point: At the end of the trial, when all participants have completed the trial	—

Measure

Time frame

Main Objective: To examine the effects of SGLT2-inhibition versus placebo on renal hemodynamics in patients with typ2 diabetes and preserved kidney function;Secondary Objective: To examine the effects of SGLT2-inhibition versus placebo on systemic hemodynamics, water- and sodium balance, tubular sodium transporters, vasoactive hormones and calcium-phosphate metabolism in patients with typ2 diabetes and preserved kidney function ;Primary end point(s): Renal Blood Flow ;Timepoint(s) of evaluation of this end point: At the end of the trial, when all participants have completed the trial

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Secondary

Measure	Time frame
Secondary end point(s): 1. GFR 2. Renal Vascular Resistance (RVF), Filtration Fraction (FF), Afferent and Efferent Renal Arteriolar Resistance (Ra and Re) 3. systemic hemodynamics: Brachial blood pressure, central blood pressure, Heart rate, pulse wave velocity and arterial stiffness. 4. Water and salt excretion: urinary sodium, Water clearence, urinary glucose, fractional sodium-excretion, urinary excretion of tubular transporter proteins (AQP2, ENaC og NCC, NKCC), Extracellular Body Water (EBW), Total Body Water (TBW), Intracellular Body Water (IBW), Adipose Tissue Mass. 5. Renin, angiotensin II, aldosterone, vasopressin, BNP 6. The NO-system measured by nitate, nitrit, cGMP and pletysmography 7. HbA1C og blood glucose 8. PTH, phosphate, calcium, FGF23, alkalic phosphatase and urinary phosphate excretion 9. Beta-hydroxybutyrate and urate 10. Urinary excretion of CL-K1 og CL-L1 11. Urinary excretion of Adenosin, NGAL, KIM-1 og IL-6 ;Timepoint(s) of evaluation of this end point: At the end of the trial, when all participants have completed the trial	—

Measure

Time frame

Secondary end point(s): 1. GFR 2. Renal Vascular Resistance (RVF), Filtration Fraction (FF), Afferent and Efferent Renal Arteriolar Resistance (Ra and Re) 3. systemic hemodynamics: Brachial blood pressure, central blood pressure, Heart rate, pulse wave velocity and arterial stiffness. 4. Water and salt excretion: urinary sodium, Water clearence, urinary glucose, fractional sodium-excretion, urinary excretion of tubular transporter proteins (AQP2, ENaC og NCC, NKCC), Extracellular Body Water (EBW), Total Body Water (TBW), Intracellular Body Water (IBW), Adipose Tissue Mass. 5. Renin, angiotensin II, aldosterone, vasopressin, BNP 6. The NO-system measured by nitate, nitrit, cGMP and pletysmography 7. HbA1C og blood glucose 8. PTH, phosphate, calcium, FGF23, alkalic phosphatase and urinary phosphate excretion 9. Beta-hydroxybutyrate and urate 10. Urinary excretion of CL-K1 og CL-L1 11. Urinary excretion of Adenosin, NGAL, KIM-1 og IL-6 ;Timepoint(s) of evaluation of this end point: At the end of the trial, when all participants have completed the trial

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Countries

Denmark

Contacts

Public ContactSteffen Flindt Nielsen

University Clinic of Nephrology and Hypertension, Regional Hospital Holstebro

steffen.nielsen@midt.rm.dk004578436588

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026