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

NCT ID: NCT00376038

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2006-10-31

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.

Conditions

Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

GSK189075 oral tablets

Intervention Type: DRUG

metformin tablets

Intervention Type: DRUG

Other Intervention Names

GSK189075 oral tablets

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Mexico City, , Mexico

Countries

Mexico

References

Hussey EK, Kapur A, O'Connor-Semmes R, Tao W, Rafferty B, Polli JW, James CD Jr, Dobbins RL. Safety, pharmacokinetics and pharmacodynamics of remogliflozin etabonate, a novel SGLT2 inhibitor, and metformin when co-administered in subjects with type 2 diabetes mellitus. BMC Pharmacol Toxicol. 2013 Apr 30;14:25. doi: 10.1186/2050-6511-14-25.

Reference Type: DERIVED

PMID: 23631443 (View on PubMed)

Other Identifiers

KG2105246

Identifier Type: -

Identifier Source: org_study_id