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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519480
First Posted: August 22, 2007
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
August 20, 2007
August 22, 2007
September 6, 2017
September 11, 2007
April 1, 2008   (Final data collection date for primary outcome measure)
  • Clinical laboratory tests, ECGs, physical exam & adverse events: [ Time Frame: 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) ]
Clinical laboratory tests, ECGs, physical exam & adverse events: Home diary of blood sugar results, adverse events and drug dosing. [ Time Frame: screening, in-clinic stays, outpatient clinic visits & follow up visit ]
Complete list of historical versions of study NCT00519480 on ClinicalTrials.gov Archive Site
  • study drug blood levels: [ Time Frame: Dosing Days 1 & 13 metformin blood levels: Days -1 & 13 ]
  • Blood glucose & insulin levels following oral glucose challenge: [ Time Frame: Dosing Days -1 & 13 ]
  • fluid intake & output [ Time Frame: dosing Days -1 - 3, 13 ]
  • study drug blood levels [ Time Frame: Dosing Days 1 & 13 ]
  • metformin blood levels [ Time Frame: Days -1 & 13 ]
  • Blood glucose & insulin levels following oral glucose challenge: [ Time Frame: Dosing Days -1 & 13 ]
  • fluid intake & output dosing [ Time Frame: Days -1 - 3, 13 ]
Not Provided
Not Provided
 
A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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.
  • Drug: Placebo
    Placebo will be available as an oral tablets.
  • Placebo Comparator: Subjects receiving treatment P
    Eligible subjects will receive placebo twice daily along with metformin twice daily for 13 days.
    Interventions:
    • Drug: Metformin
    • Drug: Placebo
  • Experimental: Subjects receiving treatment A
    Eligible subjects will receive GSK189075 500 milligrams twice daily along with metformin twice daily for 13 days.
    Interventions:
    • Drug: GSK189075
    • Drug: Metformin
  • Experimental: Subjects receiving treatment B
    Eligible subjects will receive GSK189075 750 milligrams twice daily along with metformin twice daily for 13 days.
    Interventions:
    • Drug: GSK189075
    • Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 1, 2008
April 1, 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Germany,   United States
Mexico
 
NCT00519480
KG2110243
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP