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Completed

NCT Number: NCT00519480

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK189075

Drug

GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams.

metformin

Drug

Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.

Placebo

Drug

Placebo will be available as an oral tablets.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 22, 2007
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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