A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-11

Study Completion Date

2008-04-01

Brief Summary

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This study will assess safety and tolerability of metformin plus GSK189075 in people with Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if they are receiving GSK189075 or a placebo. Participation will last about 5 weeks including a run-in period of up to 2 weeks if necessary to increase metformin up to 2000mg daily, a 13-day treatment period, and a follow-up visit about 1 week after the treatment period. Volunteers will remain in the research clinic beginning 2 days before they receive the first dose of GSK189075 until after the morning dose on the fourth day and from the afternoon of the 12th day of dosing until the morning after the last dose. They will have clinic visits on dosing Days 6, 8, and 10. Volunteers will be given equipment and instructions for measuring their blood sugar at home and will be asked to keep a study diary. Blood pressure, heart rate, laboratory tests on blood and urine, physical examinations, reports of drug side effects and ECGs will be obtained during the clinic visits to assess safety.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Subjects receiving treatment P

Eligible subjects will receive placebo twice daily along with metformin twice daily for 13 days.

Group Type PLACEBO_COMPARATOR

Metformin

Intervention Type DRUG

Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.

Placebo

Intervention Type DRUG

Placebo will be available as an oral tablets.

Subjects receiving treatment A

Eligible subjects will receive GSK189075 500 milligrams twice daily along with metformin twice daily for 13 days.

Group Type EXPERIMENTAL

GSK189075

Intervention Type DRUG

GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams.

Metformin

Intervention Type DRUG

Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.

Subjects receiving treatment B

Eligible subjects will receive GSK189075 750 milligrams twice daily along with metformin twice daily for 13 days.

Group Type EXPERIMENTAL

GSK189075

Intervention Type DRUG

GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams.

Metformin

Intervention Type DRUG

Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.

Interventions

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GSK189075

GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams.

Intervention Type DRUG

Metformin

Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.

Intervention Type DRUG

Placebo

Placebo will be available as an oral tablets.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Type 2 Diabetes for at least three months prior to study
* Diabetes treated with metformin only
* Give consent and sign an informed consent form.
* Agree to follow specific requirements of birth control during participation.

Exclusion Criteria

* Type I Diabetes.
* Treatment with insulin within 3 months prior to screening
* History of diabetic ketoacidosis or lactic acidosis
* Allergy or sensitivity to metformin or similar drugs or any medical conditions which prohibit metformin use
* Excessive blood donation 56 days before the start of the study
* Urinary tract or bladder infections within four weeks of study start
* Alcohol abuse or illicit drug use within 12 months of study start
* Receiving other investigational drugs or participating in other research trials within 30 of the study start
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements with 7-14 days of study start
* Live alone without regular, daily interactions with someone who can be an emergency contact

Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No