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Renal Actions of Combined Empagliflozin and LINagliptin in Type 2 diabetES

NCT03433248 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-01-14

No results posted yet for this study

Summary

The current study aims to explore the clinical effects and mechanistics of mono- and combination therapy with SGLT-2 inhibitor empagliflozin and DPP-4 inhibitor linagliptin on renal physiology and biomarkers in metformin-treated T2DM patients.

Conditions

  • Type2 Diabetes

Interventions

DRUG

EMPA/LINA 10/5 mg QD (n=22)

Once daily treatment with oral empagliflozin (Jardiance) 10 mg Once daily treatment with oral linagliptin (Tradjenta) 5 mg

DRUG

LINA/EMPA 5/10 mg QD (N=22)

Once daily treatment with oral linagliptin (Tradjenta) 5 mg Once daily treatment with oral empagliflozin (Jardiance) 10 mg

DRUG

Gliclazide 30 mg QD/BID (N=22)

Once daily or twice daily treatment with oral glicazide MR 30mg

Sponsors & Collaborators

  • M.H.H. Kramer

    lead OTHER

Principal Investigators

  • Mark HH Kramer, MD PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-09
Primary Completion
2021-06-01
Completion
2022-09-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03433248 on ClinicalTrials.gov