Drug Interactions From Simultaneous Administration Of Met... | NCT00376038

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

NCT00376038

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Jun 4, 2012Estimated

Enrollment

13Actual

Phase

Phase 1

Conditions

Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2

Interventions

GSK189075 oral tablets
metformin tablets

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Aug 2006

Primary Completion Date

Oct 2006Actual

Completion Date

Oct 2006Actual

First Submitted Date

Sep 12, 2006

First Submission Date that Met QC Criteria

Sep 12, 2006

First Posted Date

Sep 14, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2012

Last Update Posted Date

Jun 4, 2012Estimated

Description Module

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 Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Name	Type	Description	Arm Group Labels	Other Names
GSK189075 oral tablets	Drug
metformin tablets	Drug			GSK189075 oral tablets

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Blood levels of drugs at Day 3 Evaluation of efficacy and safety markers on Days 1, 2, and 3.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Mexico City		14050	Mexico

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23631443	Derived	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.

ID	Term
D003924	Diabetes Mellitus, Type 2
D009765	Obesity
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals