Status:

COMPLETED

A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Diabetes Mellitus Type 2

Eligibility:

All Genders

18-75 years

Phase:

PHASE1

Brief Summary

This study will assess the potential pharmacodynamic and potential pharmacokinetic interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not adequately controlled with glybur...

Eligibility Criteria

Inclusion

  • adult patients, aged 18-75 years;
  • type 2 diabetes mellitus; currently on glyburide 10-20 mg/day for \>=3 months;
  • untreated, or taken off anti-diabetic or statin therapy \>=2 weeks before study start.

Exclusion

  • type 1 diabetes mellitus, or latent autoimmune diabetes in adults;
  • diabetic neuropathy, retinopathy or nephropathy;
  • patients treated with insulin or PPAR gamma agonist with 6 weeks of screening.

Key Trial Info

Start Date :

October 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2007

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT00388986

Start Date

October 1 2006

End Date

July 1 2007

Last Update

November 2 2016

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Cypress, California, United States, 90630

2

Honolulu, Hawaii, United States, 96813

3

Buffalo, New York, United States, NY 14215

4

San Antonio, Texas, United States, 78229