Comparing the Renal Effect of Dipeptidyl-peptidase 4 Inhibitors and Sulfonylureas

NCT03983551 | Completed Phase 4 DMC

• 1 other identifier: 190512
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dipeptidyl peptidase 4 (DPP-4) inhibitors and sulfonylureas have been extensively used in the treatment of type 2 diabetes mellitus (T2DM). Although both medications effectively lower plasma glucose levels, differences may exist in their pharmacokinetics and effect on the kidney. In the context of diabetic kidney disease, DPP-4 inhibitors may confer renal protection through several putative mechanisms. In contrast, sulfonylureas are associated with weight gain and cardiac dysfunction, which may adversely influence kidney function. The investigators hypothesize that DPP-4 inhibitors and sulfonylureas may have a different effect on the diabetic kidney. This study compares the effect of DPP-4 inhibitors and sulfonylureas on urinary albumin excretion in patients with newly diagnosed T2DM.

Conditions

Type 2 Diabetes Mellitus; Proteinuria

Keywords

Type 2 diabetes mellitus; dipeptidyl peptidase 4 inhibitors; sulfonylureas; proteinuria

Outcome Measures

Primary Outcomes (1)

• Change in urinary albumin-to-creatinine ratio

  Change in urinary albumin-to-creatinine ratio after pharmacologic treatment

  24 weeks

Secondary Outcomes (4)

• Change in serum glycated hemoglobin A1c

  24 weeks

• Change in body weight

  24 weeks

• Change in serum creatinine

  24 weeks

• Change in systolic blood pressure

  24 weeks

Study Arms (2)

Dipeptidyl peptidase 4 inhibitors

EXPERIMENTAL

Vildagliptin 50 milligrams twice daily in addition to metformin 1000 milligrams once daily

Drug: Dipeptidyl Peptidase 4 Inhibitor

Sulfonylureas

ACTIVE COMPARATOR

Glimepiride 2 milligrams twice daily in addition to metformin 1000 milligrams once daily

Drug: Sulfonylurea

Interventions

Dipeptidyl Peptidase 4 Inhibitor DRUG

Vildagliptin 50 milligrams twice daily in addition to metformin 1000 milligrams once daily

Also known as: DPP-4 inhibitor

Dipeptidyl peptidase 4 inhibitors

Sulfonylurea DRUG

Glimepiride 2 milligrams twice daily in addition to metformin 1000 milligrams once daily

Also known as: SU

Sulfonylureas

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients exceeding 20 years of age
• Patients with newly diagnosed type 2 diabetes mellitus
• Patients who have yet to receive antidiabetic medications

You may not qualify if:

• Patients with non-diabetic kidney disease
• Patients with congenital kidney abnormalities
• Patients with end stage renal disease.
• Patients who have received angiotensin-converting-enzyme inhibitor or angiotensin II receptor blocker

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Related Publications (8)

• Park CW. Diabetic kidney disease: from epidemiology to clinical perspectives. Diabetes Metab J. 2014 Aug;38(4):252-60. doi: 10.4093/dmj.2014.38.4.252.

  PMID: 25215271 BACKGROUND

• Stanton RC. Clinical challenges in diagnosis and management of diabetic kidney disease. Am J Kidney Dis. 2014 Feb;63(2 Suppl 2):S3-21. doi: 10.1053/j.ajkd.2013.10.050.

  PMID: 24461728 BACKGROUND

• Mishra R, Emancipator SN, Kern T, Simonson MS. High glucose evokes an intrinsic proapoptotic signaling pathway in mesangial cells. Kidney Int. 2005 Jan;67(1):82-93. doi: 10.1111/j.1523-1755.2005.00058.x.

  PMID: 15610231 BACKGROUND

• Kim MK. Treatment of diabetic kidney disease: current and future targets. Korean J Intern Med. 2017 Jul;32(4):622-630. doi: 10.3904/kjim.2016.219. Epub 2017 Jun 30.

  PMID: 28704915 BACKGROUND

• Introduction: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S1-S2. doi: 10.2337/dc18-Sint01. No abstract available.

  PMID: 29222369 BACKGROUND

• Davidson JA. The placement of DPP-4 inhibitors in clinical practice recommendations for the treatment of type 2 diabetes. Endocr Pract. 2013 Nov-Dec;19(6):1050-61. doi: 10.4158/EP12303.RA.

  PMID: 24126227 BACKGROUND

• Makino Y, Fujita Y, Haneda M. Dipeptidyl peptidase-4 inhibitors in progressive kidney disease. Curr Opin Nephrol Hypertens. 2015 Jan;24(1):67-73. doi: 10.1097/MNH.0000000000000080.

  PMID: 25415611 BACKGROUND

• Sola D, Rossi L, Schianca GP, Maffioli P, Bigliocca M, Mella R, Corliano F, Fra GP, Bartoli E, Derosa G. Sulfonylureas and their use in clinical practice. Arch Med Sci. 2015 Aug 12;11(4):840-8. doi: 10.5114/aoms.2015.53304. Epub 2015 Aug 11.

  PMID: 26322096 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Proteinuria

Interventions

Dipeptidyl-Peptidase IV Inhibitors; Sulfonylurea Compounds

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Shih Te Tu, MD

  Changhua Christian Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 12, 2019
• Study Start: March 1, 2016
• Primary Completion: February 10, 2018
• Study Completion: February 28, 2018
• Last Updated: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting immediately after publication.
• Access Criteria: Available to any interested researcher.