CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 101 enrolled
Drug / intervention
Dipeptidyl Peptidase 4 Inhibitor +1 moredrug
Likely dose
Dipeptidyl Peptidase 4 Inhibitor 50 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03983551
NCT03983551Phase 4Completed

Comparing the Effect of Dipeptidyl-peptidase 4 Inhibitors and Sulfonylureas on Urinary Albumin Excretion in People With Type 2 Diabetes Mellitus

Changhua Christian Hospital·interventional·Posted Jun 12, 2019·Updated Jun 14, 2019

In Brief

A Phase 4 clinical trial evaluating Dipeptidyl Peptidase 4 Inhibitor and Sulfonylurea for Type 2 Diabetes Mellitus and Proteinuria. Completed, enrolled 101 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
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Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 12, 2019
Enrollment StartMar 1, 2016
Primary CompletionFeb 10, 2018
Study CompletionFeb 28, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.1 years ago

Interventions

Dipeptidyl Peptidase 4 Inhibitordrug

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

Sulfonylureadrug

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