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Assessing the Behavior of Met DR in Subjects With Kidney Dysfunction

NCT01658514 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2015-12-30

Study results available
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Summary

This study evaluated how a single dose of delayed-release metformin (Met DR) behaves in subjects with normal kidney function, mild kidney dysfunction, moderate kidney dysfunction, or severe kidney dysfunction. The safety and tolerability of Met DR was also examined. In addition, this study compared the behavior of a single dose of Met DR with that of extended-release metformin (Met XR) and placebo in subjects with the varying levels of kidney function described above.

Conditions

  • Renal Insufficiency

Interventions

DRUG

Met DR

metformin delayed-release tablets

DRUG

Met XR

metformin extended-release tablets

DRUG

Placebo

Sponsors & Collaborators

  • Elcelyx Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • George Canas, MD · Prism Research

  • Kenneth Lasseter, MD · Clinical Pharmacology of Miami, Inc

  • Alexander White, MD · Progressive Medical Research

  • Harold Bays, MD · Louisville Metabolic and Atherosclerosis Research Center

  • Craig Curtis, MD · Compass Research

  • Prabir Roy-Chaudhury · Cincinnati Veterans Affairs Medical Center Department of Internal Medicine

  • Sunder Mudaliar · San Diego Veterans Healthcare System

  • Nelson Kopyt · Northeast Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-06-30
Completion
2014-06-30

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Drugs

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 NCT01658514 on ClinicalTrials.gov