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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Metabolic Effects of the SGLT-2 Inhibitor Empagliflozin in Patients With Diabetic Nephropathy (MEDiaN)

Clinicaltrials.gov identifier NCT03933956

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted March 19, 2020

Study Description

Brief summary:

The MEDiaN study aims to examine the state of fuel metabolism in participants with diabetic nephropathy (DN) before and after the use of the sodium-glucose transport protein 2 inhibitor (SGLT-2i) empagliflozin. The goals of the MEDiaN study are to better understand the contribution of fuel metabolism to the development of DN, and to determine if changes to fuel metabolism can have a positive impact on this disease. The MEDiaN study is a single-center single-arm open-label intervention study to examine the effects of empagliflozin 10mg daily taken for 30 days on fuel oxidation patterns in participants with type 2 diabetes and DN.

  • Condition or Disease:Diabetic Nephropathies
  • Intervention/Treatment: Drug: Empagliflozin 10 MG
  • Phase: Phase 3
Detailed Description

Diabetic nephropathy (DN) is a common cause of end-stage renal disease. MEDiaN study investigators hypothesize that dysregulated mitochondrial fuel oxidation is a major driver of diabetic nephropathy. The sodium-glucose transport protein 2 inhibitor (SGLT-2i) empagliflozin has been shown to slow the progression of DN in patients with diabetes. The MEDiaN study aims to examine the state of fuel metabolism in participants with DN before and after the use of the SGLT-2i empagliflozin. The goals of the MEDiaN study are to better understand the contribution of fuel metabolism to the development of DN, and to determine if changes to fuel metabolism can have a positive impact on this disease. The MEDiaN study is a single-center single-arm open-label intervention study to examine the effects of empagliflozin 10mg daily taken for 30 days on fuel oxidation patterns in participants with type 2 diabetes and DN. The MEDiaN study plans to recruit 40 participants aged 21 to 100 years of age with type 2 diabetes mellitus and diabetic nephropathy. Participants will receive treatment with oral empagliflozin 10mg daily for 30 days. The state of fuel metabolism will be examined through metabolomics analysis of blood and urine samples before and after empagliflozin 10mg daily taken for 30 days.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Single-arm open-label intervention study
  • Masking: None (Open Label) ()
  • Primary Purpose: Basic Science
  • Official Title: Metabolic Effects of the SGLT-2 Inhibitor Empagliflozin in Patients With Diabetic Nephropathy (MEDiaN)
  • Estimated Study Start Date: May 2020
  • Estimated Primary Completion Date: August 2020
  • Estimated Study Completion Date: August 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Empagliflozin-treated
Oral empagliflozin tablets 10mg daily, taken for 30 days.
Drug: Empagliflozin 10 MG
Oral empagliflozin 10mg daily for 30 days
Outcome Measures
  • Primary Outcome Measures: 1. Change in ketone signature [ Time Frame: Baseline and after 30 days of treatment with empagliflozin 10mg daily ]
    Change in ketone signature following 30 days of empagliflozin treatment
  • 2. Change in lipid metabolome signature [ Time Frame: Baseline and after 30 days of treatment with empagliflozin 10mg daily ]
    Change in lipid metabolome signature following 30 days of empagliflozin treatment
  • 3. Change in amino acid metabolome signature [ Time Frame: Baseline and after 30 days of treatment with empagliflozin 10mg daily ]
    Change in amino acid metabolome signature following 30 days of empagliflozin treatment
Eligibility Criteria
  • Ages Eligible for Study: 21 to 100 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion criteria:

1. Man or woman between 21 and 100 years of age

2. Type 2 diabetes mellitus as defined by:

- Fasting plasma glucose ≥7.0mmol/l, or

- Symptoms of hyperglycemia with casual plasma glucose ≥11.1 mmol/L, or

- 2-hour plasma glucose ≥11.1 mmol/l after a 75-gram oral glucose load, or

- Known type 2 diabetes mellitus diagnosed by a medical practitioner

3. Two or more measurements indicating increased urine protein excretion within 1-year

Increased urine protein excretion is defined as:

- Urine microalbumin/creatinine ratio (ACR) > 3.3 mg/mmol creatinine or

- Urine total protein/creatinine ratio (PCR) > 0.2 g/urine creatinine

4. Known diabetes duration > 3 months

5. HbA1c ≤9% (within 3 months prior to enrolment)

6. Not currently treated with an SGLT-2 inhibitor, and have not received SGLT-2 inhibitor
therapy within the last 10 weeks.

7. Stable diabetes therapy for at least 3months as defined as:

- No increase in dose of diabetes medications by more than two-fold or

- No new agents added within the previous 3 months

8. Stable doses of angiotensin converting enzyme (ACE) inhibitors or angiotensin
AT(1)-receptor blockers (ARBs) for at least 3 months.

9. Capable of providing informed consent

Exclusion Criteria:

1. Type 1 diabetes mellitus

2. Ketosis-prone diabetes

3. Previous diabetic ketoacidosis

4. History of Fournier's gangrene or skin and soft tissue infections of the perineum

5. Recurrent or severe urinary tract or genital mycotic infections, or history of
genitourinary infection within 2 weeks prior to informed consent

6. Significant renal impairment (estimated Glomerular Filtration Rate < 45 ml/min/1.73m2**) 7. Dialysis or kidney transplant 8. Renal artery stenosis 9. Alanine aminotransferase or aspartate aminotransferase above 3x upper limit of normal 10. Significant change in weight (≥10% in the preceding 6 months) 11. Treatment with anti-obesity drugs 12. Previous bariatric surgery or other gastrointestinal surgeries that induce chronic malabsorption 13. Treatment with systemic glucocorticoids 14. Blood dyscrasias or clinically significant anaemia (Haemoglobin 1 unit per day for women and > 2 units per day for men)

22. History of drug abuse

23. Pancreatic insulin deficiency from any cause (history of pancreatitis, pancreatic
surgery)

24. Known intolerance or allergic reactions to empagliflozin or other SGLT-2 inhibitors

25. Current participation in another clinical trial, or ingestion of investigational drug
in another trial within 30 days prior to enrolment.

26. Presence of any non-DN renal glomerular disease (e.g. IgA nephropathy, lupus
nephritis, membranous glomerulonephritis, focal segmental glomerular sclerosis)

27. Any previous organ transplantation

28. Any factors likely to limit adherence to interventions (e.g. dementia; alcohol or
substance abuse; history of unreliability in medication taking or appointment keeping;
significant concerns about participation in the study from spouse, significant other
or family members)

29. Failure to obtain informed consent from participant

30. Presence of postural hypotension or clinically significant dehydration (reduced skin
turgor, dry oral mucosa, hypotension)

Contacts and Locations
Contacts

Contact: Yun Rui Amanda Lam, MBBS MRCP (65)63214654 amanda.lam.y.r@singhealth.com.sg

Contact: Hong Chang Tan, MBBS MRCP (65)63214654 tan.hong.chang@singhealth.com.sg

Locations

Singapore
Singapore General Hospital
Singapore

Sponsors and Collaborators

Singapore General Hospital

Duke-NUS Graduate Medical School

Investigators

Principal Investigator: Yun Rui Amanda Lam, MBBS MRCP Singapore General Hospital

More Information