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

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 Intervention Phase
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
 Drug: GSK189075
Drug: Metformin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Placebo plus Metformin Drug: Metformin
Experimental: GSK189075 500mg plus Metformin Drug: GSK189075
Other Name: GSK189075
Experimental: GSK189075 750mg plus Metformin Drug: GSK189075
Other Name: GSK189075

  Eligibility

Ages Eligible for Study:   30 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519480

Locations
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33169
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78209
Argentina
GSK Investigational Site
Buenos Aires, Argentina, 1425
Germany
GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00519480     History of Changes
Other Study ID Numbers: KG2110243
Study First Received: August 20, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Tolerability
GSK189075,
Metformin,
Safety,
Diabetes,

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013