Status:

TERMINATED

A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18-75 years

Phase:

PHASE1

Brief Summary

This study will investigate the effect of hepatic impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of GK Activator (2) in type 2 diabetes patients with mild and moderate h...

Eligibility Criteria

Inclusion

  • adult patients, 18-75 years of age;
  • type 2 diabetes;
  • normal hepatic function, or mild or moderate hepatic impairment.

Exclusion

  • type 1 diabetes, or latent autoimmune diabetes in adults;
  • diabetic neuropathy, retinopathy or nephropathy;
  • treatment with insulin or PPAR gamma agonist within 6 weeks of screening;
  • clinically significant cardiovascular disease.

Key Trial Info

Start Date :

March 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2007

Estimated Enrollment :

2 Patients enrolled

Trial Details

Trial ID

NCT00437606

Start Date

March 1 2007

End Date

June 1 2007

Last Update

August 24 2016

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Berlin, Germany

2

Kiel, Germany

3

Bratislava, Slovakia

A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment. | DecenTrialz