CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
Linagliptin +1 moredrug
Likely dose
Linagliptin 5 mgfrom 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/NCT02467478
NCT02467478Phase 4Completed

Role of Linagliptin in Improving Renal Failure by Improving CD34+ Stem Cell Number, Function and Gene Expression in Renal Function Impaired Type 2 Diabetes Patients.

George Washington University·interventional·Posted Jun 10, 2015·Updated Jan 19, 2023

In Brief

A Phase 4 clinical trial evaluating Linagliptin and Placebo for Type 2 Diabetes and Impaired Renal Function. Completed, enrolled 31 participants across 1 site.

Detailed Summary

Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels which may contribute to heart disease. Endothelial Progenitor Cells (EPCs) are found in the blood. Research has shown that improving the survival of these special blood cells may decrease the harmful effects of diabetes on blood vessels and reduce or reverse heart disease. Linagliptin is an Food and Drug Administration (FDA) approved prescription medicine used along with insulin or with oral medications to lower blood sugar in people with Type 2 diabetes. It is in a class of diabetes medication called Dipeptidyl peptidase-4 (DPP-4) inhibitors. DPP-4 inhibitors have been shown to increase EPCs in patients with Type 2 diabetes. Hypothesis: Both type 2 diabetes and Chronic Kidney Disease (CKD) are associated with poor stem cell number and function. Poor viability and function of EPCs in CKD and diabetes The investigators hypothesize that use of Linagliptin (along with Insulin) may help reduce cardiovascular risk by improving EPC survival and function above and beyond adequate glucose metabolism control

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 10, 2015
Enrollment StartApr 1, 2015
Primary CompletionApr 1, 2019
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 11.1 years ago

Interventions

Linagliptindrug

5 mg tablet once daily for 12 weeks

Placebodrug

1 tablet daily for 12 weeks