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

September 1, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 14050
        • GSK Investigational Site
  • United States
    • Florida
      • Miami, Florida, United States, 33169
        • GSK Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78209
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: Metformin
Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.
Drug: GSK189075
GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams.
Experimental: Subjects receiving treatment B
Eligible subjects will receive GSK189075 750 milligrams 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: GSK189075
GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (Estimate)

August 22, 2007

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KG2110243

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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