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A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.

NCT00368368 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-11-02

No results posted yet for this study

Summary

This study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. Patients will be assigned to treatment groups according to their renal function (normal, moderate renal impairment, or severe renal impairment). After a 1 week washout period from current oral anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

GK Activator (2)

100mg po

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States
  • Slovakia

Study Locations

More Related Trials

Entities

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 NCT00368368 on ClinicalTrials.gov