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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

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ClinicalTrials.gov Identifier: NCT00519480
Recruitment Status : Completed
First Posted : August 22, 2007
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: GSK189075 Drug: Metformin Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : September 11, 2007
Actual Primary Completion Date : April 1, 2008
Actual Study Completion Date : April 1, 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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: 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.
Experimental: Subjects receiving treatment B
Eligible subjects will receive GSK189075 750 milligrams twice daily along with metformin twice daily for 13 days.
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.



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

Secondary Outcome Measures :
  1. study drug blood levels: [ Time Frame: Dosing Days 1 & 13 metformin blood levels: Days -1 & 13 ]
  2. Blood glucose & insulin levels following oral glucose challenge: [ Time Frame: Dosing Days -1 & 13 ]
  3. fluid intake & output [ Time Frame: dosing Days -1 - 3, 13 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00519480     History of Changes
Other Study ID Numbers: KG2110243
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017

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