Last updated: 11/04/2018 08:29:45
Drug Interactions From Simultaneous Administration Of Metformin And GSK189075 To Subjects With Type 2 Diabetes
GSK study ID
KG2105246
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GSK189075 oral tablets
Drug: metformin tablets
Enrollment:
13
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Type 2 Diabetes Mellitus
Product
remogliflozin etabonate
Collaborators
Not applicable
Study date(s)
August 2006 to October 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
30 - 64 years
Accepts healthy volunteers
No
- Have Type 2 diabetes mellitus.
- Have a Body Mass Index within range 22 to 35kg/m2 inclusive.
- Are currently taking insulin therapy.
- Have any disease (such as heart, liver, blood, nervous system, or kidney disease, or cancer).
Inclusion and exclusion 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.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-27-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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