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Renal and Peripheral Hemodynamic Function in Patients With Type 1 Diabetes Mellitus

NCT00297401 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-08-29

No results posted yet for this study

Summary

Protein kinase C (PKC), an enzyme in the body, has been implicated in the process of diabetic microvascular complications. The purpose of this study will be to evaluate the renal hemodynamic and peripheral vascular effects of PKC inhibition with ruboxistaurin mesylate (an inhibitor of PKC) in patients with Type 1 diabetes mellitus and evidence of early nephropathy. In this pilot study, 21 patients with type 1 diabetes were planned to be randomized to LY333531 or placebo in a 2:1 fashion, after an initial period of testing. After 8 weeks of study drug, patients were retested.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

ruboxistaurin

32 mg, QD, PO, up to 8 weeks

DRUG

placebo

QD, PO, up to 8 weeks

Sponsors & Collaborators

  • Heart and Stroke Foundation of Canada

    collaborator OTHER

  • Chromaderm, Inc.

    lead INDUSTRY

Principal Investigators

  • Karl Beutner · Chromaderm, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT00297401 on ClinicalTrials.gov