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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00376038
First received: September 12, 2006
Last updated: May 31, 2012
Last verified: February 2011
History of Changes
  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
Diabetes Mellitus, Type 2
 Drug: GSK189075 oral tablets
Drug: metformin tablets
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

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)
Intervention Details:
    Drug: GSK189075 oral tablets Drug: metformin tablets
    Other Names:
    • metformin tablets
    • GSK189075 oral tablets
  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 GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00376038     History of Changes
Other Study ID Numbers: KG2105246
Study First Received: September 12, 2006
Last Updated: May 31, 2012
Health Authority: Mexico: Ministry of Health
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GSK189074
T2DM
GSK189075
Glucophage
Obesity
 Diabetes
Metformin
Type 2 Diabetes Mellitus
Drug Interaction

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013