Drug Interactions From Simultaneous Administration Of Metformin And GSK189075 To Subjects With Type 2 Diabetes
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: GSK189075 oral tablets (Drug); metformin tablets (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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. This study will evaluate the effect of GSK189075 on metformin levels in
the blood in T2DM subjects. The rationale is to look for any safety problems that may result
when the 2 drugs are given together.
Clinical Details
Official title: A Randomized Open-Label, Repeat Dose, Two Sequence Cross-Over Study to Determine the Effect of GSK189075 on the Pharmacokinetic Parameters of Metformin (Glucophage) in Subjects With Type 2 Diabetes Mellitus.
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Blood concentrations of metformin when given with GSK189075 in T2DM subjects over 3-day course
Lab tests, changes in blood pressure and heart rate and heart activity on EKG machine
Secondary outcome: Blood levels of drugs at Day 3
Evaluation of efficacy and safety markers on Days 1, 2, and 3.
Eligibility
Minimum age: 30 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
GSK Clinical Trials Call Center, Mexico City 14050, Mexico
Additional Information
Starting date: May 2006
Ending date: October 2006
Last updated: April 16, 2008
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