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Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration

NCT02911792 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-11-30

Study results available
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Summary

The investigators propose to treat newly diagnosed, hyperfiltering T2DM patients with or without microalbuminuria with dapagliflozin or metformin for 4 months. The metformin-treated group will serve as controls for improved glycemic control, since the investigators have shown that insulin therapy to normalize A1c reduces hyperfiltration and kidney size in T1DM patients.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Dapagliflozin

SGLT2 inhibitor

DRUG

Metformin

Oral diabetes medicine that helps control blood sugar levels.

DRUG

Glipizide 5 MG

Oral diabetes medicine that helps control blood sugar levels.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Ralph DeFronzo, MD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-20
Primary Completion
2023-07-11
Completion
2023-07-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT02911792 on ClinicalTrials.gov