Status:
COMPLETED
Drug Interactions From Simultaneous Administration Of Metformin And GSK189075 To Subjects With Type 2 Diabetes
Lead Sponsor:
GlaxoSmithKline
Conditions:
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-64 years
Phase:
PHASE1
Brief Summary
GSK189075 is intended for use as a single treatment or in combination with other treatments for tye 2 diabetes mellitus (T2DM). Metformin is widely used in Europe and the USA for the treatment of T2DM...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Have Type 2 diabetes mellitus.
- Have a Body Mass Index within range 22 to 35kg/m2 inclusive.
- Females who meet above criteria must be physiologically incapable of becoming pregnant (i.e., surgically sterilized, or post-menopausal per protocol definition).
- Exclusion criteria:
- Are currently taking insulin therapy.
- Have any disease (such as heart, liver, blood, nervous system, or kidney disease, or cancer).
- Have a history of stomach, liver, kidney, or other disease that with interfere with taking the study drug.
- Are currently using diuretics, oral or injectable corticosteroids (inhaled \& intranasal corticosteroids are permitted), or other medications that would cause you to deplete your fluid balance in your body; currently taking stable regimens for heart conditions; currently using prescription or non-prescription drugs within 7 days of starting the study that may interfere with the study drug.
- Would donate more than 450 ML of blood over a 2 month period.
- Physician does not think it is a good idea for you to participate in the trial. - Had a urinary tract infection or bladder infection in the last month. - Are currently drinking more than 2 beers, 1 glass of wine, or 1 glass of spirits daily.
- Have a positive urine drug screen test.
- Plan to change your smoking habits during the course of the trial.
- Have Hepatitis C, Hepatitis B, or HIV. - Have a lab or EKG abnormality. - High or low blood pressure.
- Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
- Are a male subject unwilling to abstain or use protection during intercourse.
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00376038
Start Date
August 1 2006
End Date
October 1 2006
Last Update
June 4 2012
Active Locations (1)
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1
GSK Investigational Site
Mexico City, Mexico, 14050