Drug Interactions From Simultaneous Administration Of Metformin And GSK189075 To Subjects With Type 2 Diabetes

Overview[ - collapse ][ - ]

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.
ConditionType 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
InterventionDrug: GSK189075 oral tablets
Drug: metformin tablets
PhasePhase 1
SponsorGlaxoSmithKline
Responsible PartyGlaxoSmithKline
ClinicalTrials.gov IdentifierNCT00376038
First ReceivedSeptember 12, 2006
Last UpdatedMay 31, 2012
Last verifiedFebruary 2011

Tracking Information[ + expand ][ + ]

First Received DateSeptember 12, 2006
Last Updated DateMay 31, 2012
Start DateAugust 2006
Estimated Primary Completion DateOctober 2006
Current Primary Outcome MeasuresBlood 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
Current Secondary Outcome MeasuresBlood levels of drugs at Day 3 Evaluation of efficacy and safety markers on Days 1, 2, and 3.

Descriptive Information[ + expand ][ + ]

Brief TitleDrug Interactions From Simultaneous Administration Of Metformin And GSK189075 To Subjects With Type 2 Diabetes
Official TitleA 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.
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. 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Type 2 Diabetes Mellitus
  • Diabetes Mellitus, Type 2
InterventionDrug: GSK189075 oral tablets
Drug: metformin tablets
Other Names:
  • metformin tablets
  • GSK189075 oral tablets
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment13
Estimated Completion DateOctober 2006
Estimated Primary Completion DateOctober 2006
Eligibility 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.
GenderBoth
Ages30 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesMexico

Administrative Information[ + expand ][ + ]

NCT Number NCT00376038
Other Study ID NumbersKG2105246
Has Data Monitoring CommitteeNot Provided
Information Provided ByGlaxoSmithKline
Study SponsorGlaxoSmithKline
CollaboratorsNot Provided
Investigators Study Director: GSK Clinical Trials GlaxoSmithKline
Verification DateFebruary 2011

Locations[ + expand ][ + ]

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