Drug Interactions From Simultaneous Administration Of Metformin And GSK189075 To Subjects With Type 2 Diabetes - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00376038

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: GSK189075 oral tablets Drug: metformin tablets	Phase I

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics/Dynamics Study
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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Measures:

Blood levels of drugs at Day 3 Evaluation of efficacy and safety markers on Days 1, 2, and 3.

Enrollment:	13
Study Start Date:	August 2006
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	30 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376038

Locations

Mexico
GSK Investigational Site
Mexico, D.F., Mexico, 14050

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	KG2105246
Study First Received:	September 12, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00376038
Health Authority:	United States: Food and Drug Administration; Mexico: Ministry of Health

Keywords provided by GlaxoSmithKline:

Type 2 Diabetes Mellitus
T2DM
Diabetes
Obesity
Drug Interaction

Metformin
Glucophage
GSK189075
GSK189074

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009