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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00519480

Collaborator

(none)

Enrollment

Locations

Arms

6.7

Actual Duration (Months)

12.5

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: GSK189075 Drug: Metformin Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Two-Week, Randomized, Double-Blind, Repeat-Dose, Parallel-Group Study to Evaluate the Safety and Tolerability of Metformin > 2000mg Co-Administered With Either GSK189075 500mg BID or GSK 189075 750mg BID to Subjects With Type 2 Diabetes Mellitus

Actual Study Start Date :

Sep 11, 2007

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Subjects receiving treatment P Eligible subjects will receive placebo twice daily along with metformin twice daily for 13 days.	Drug: Metformin Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams. Drug: Placebo Placebo will be available as an oral tablets.
Experimental: Subjects receiving treatment A Eligible subjects will receive GSK189075 500 milligrams twice daily along with metformin twice daily for 13 days.	Drug: GSK189075 GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams. Drug: Metformin Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.
Experimental: Subjects receiving treatment B Eligible subjects will receive GSK189075 750 milligrams twice daily along with metformin twice daily for 13 days.	Drug: GSK189075 GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams. Drug: Metformin Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.

Arm

Intervention/Treatment

Placebo Comparator: Subjects receiving treatment P

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

Drug: Metformin

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

Drug: Placebo

Placebo will be available as an oral tablets.

Experimental: Subjects receiving treatment A

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

Drug: GSK189075

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

Drug: Metformin

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

Experimental: Subjects receiving treatment B

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

Drug: GSK189075

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

Drug: Metformin

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

Outcome Measures

Primary Outcome Measures

Clinical laboratory tests, ECGs, physical exam & adverse events: [screening, in-clinic stays, outpatient clinic visits & follow up visit (approximately 50 days)]
Home diary of blood sugar results, adverse events and drug dosing. [throughout the study (approximately 50 days)]

Secondary Outcome Measures

study drug blood levels: [Dosing Days 1 & 13 metformin blood levels: Days -1 & 13]
Blood glucose & insulin levels following oral glucose challenge: [Dosing Days -1 & 13]
fluid intake & output [dosing Days -1 - 3, 13]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Miami	Florida	United States	33169
2	GSK Investigational Site	San Antonio	Texas	United States	78209
3	GSK Investigational Site	Buenos Aires		Argentina	1425
4	GSK Investigational Site	Berlin		Germany	14050