Drug Interactions From Simultaneous Administration Of Metformin And GSK189075 To Subjects With Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT00376038 |
Recruitment Status :
Completed
First Posted : September 14, 2006
Last Update Posted : June 4, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 | Drug: GSK189075 oral tablets Drug: metformin tablets | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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. |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | October 2006 |
Actual Study Completion Date : | October 2006 |

- Drug: GSK189075 oral tablets
- Drug: metformin tablets
Other Name: GSK189075 oral tablets
- 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
- Blood levels of drugs at Day 3 Evaluation of efficacy and safety markers on Days 1, 2, and 3.

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Ages Eligible for Study: | 30 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376038
Mexico | |
GSK Investigational Site | |
Mexico, D.F., Mexico, 14050 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00376038 |
Other Study ID Numbers: |
KG2105246 |
First Posted: | September 14, 2006 Key Record Dates |
Last Update Posted: | June 4, 2012 |
Last Verified: | February 2011 |
GSK189074 T2DM GSK189075 Glucophage Obesity |
Diabetes Metformin Type 2 Diabetes Mellitus Drug Interaction |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Metformin Hypoglycemic Agents Physiological Effects of Drugs |