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:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00519480
First received: August 20, 2007
Last updated: May 31, 2012
Last verified: May 2011

August 20, 2007
May 31, 2012
September 2007
April 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) ] [ Designated as safety issue: No ]
  • Home diary of blood sugar results, adverse events and drug dosing. [ Time Frame: throughout the study (approximately 50 days) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Blood glucose & insulin levels following oral glucose challenge: [ Time Frame: Dosing Days -1 & 13 ] [ Designated as safety issue: No ]
  • fluid intake & output [ Time Frame: dosing Days -1 - 3, 13 ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Drug: GSK189075
    Other Name: GSK189075
  • Drug: Metformin
  • Active Comparator: Placebo plus Metformin
    Intervention: Drug: Metformin
  • Experimental: GSK189075 500mg plus Metformin
    Intervention: Drug: GSK189075
  • Experimental: GSK189075 750mg plus Metformin
    Intervention: Drug: GSK189075
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2008
April 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
Both
30 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Germany
 
NCT00519480
KG2110243
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2011

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