Last updated: 11/04/2018 08:31:17

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

GSK study ID
KG2110243
See study documents
Clinicaltrials.gov ID
NCT00519480
EudraCT ID
2007-004224-20
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Clinical laboratory tests, ECGs, physical exam & adverse events:

Timeframe: screening, in-clinic stays, outpatient clinic visits & follow up visit (approximately 50 days)

Home diary of blood sugar results, adverse events and drug dosing.

Timeframe: throughout the study (approximately 50 days)

Secondary outcomes:

study drug blood levels:

Timeframe: Dosing Days 1 & 13 metformin blood levels: Days -1 & 13

Blood glucose & insulin levels following oral glucose challenge:

Timeframe: Dosing Days -1 & 13

fluid intake & output

Timeframe: dosing Days -1 - 3, 13

Interventions:
  • Drug: GSK189075
  • Drug: Metformin
  • Drug: Placebo
    • Enrollment:
    50
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    remogliflozin etabonate
    Collaborators
    Not applicable
    Study date(s)
    September 2007 to April 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    30 - 64 years
    Accepts healthy volunteers
    No
    • Diagnosed with Type 2 Diabetes for at least three months prior to study
    • Diabetes treated with metformin only
    • Type I Diabetes.
    • Treatment with insulin within 3 months prior to screening
    Inclusion and exclusion criteria
    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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33169
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78209
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Buenos Aires, Buenos Aires, Argentina, 1425
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14050
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2008-01-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study KG2110243 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
    Visit website