A Study To Compare Effects Of GSK189075 In Combination With Either Furosemide Or Hydrochlorothiazide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00671424
First received: April 30, 2008
Last updated: March 15, 2012
Last verified: February 2011
  Purpose

Many patients with type 2 diabetes also have conditions that are treated with diuretics. The patients may also be treated with GSK189075 for their diabetes. This study is planned to assess possible effects of administering GSK189075 in combination with two frequently used diuretics.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Drug: Hydrochlorothiazide (HCTZ)
Drug: Remogliflozin etabonate (GSK189075)
Drug: Furosemide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Evaluation of the Safety, Tolerability, and Pharmacodynamic Effects of GSK189075 When Administered With Furosemide or Hydrochlorothiazide

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Serum sodium and potassium concentrations: [ Time Frame: baseline, Day 3, and Days 9-15 ]

Secondary Outcome Measures:
  • adverse events: [ Time Frame: each visit ]
  • Physical Exam: [ Time Frame: screening,Days -1,15,follow-up ]
  • ECG & vital signs: [ Time Frame: Days -1,3,8,9,14,15,follow-up ]
  • Clinical labs:screening: [ Time Frame: Days -1,3,8-15,follow-up ]
  • blood pressure: [ Time Frame: days 7,13 ]
  • urine labs: [ Time Frame: Days 7,8,9,13,14 ]
  • weight: [ Time Frame: Days -1,3,4,9,10,15 ]

Estimated Enrollment: 48
Study Start Date: March 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Hydrochlorothiazide (HCTZ) Drug: Remogliflozin etabonate (GSK189075) Drug: Furosemide
    Other Names:
    • Remogliflozin etabonate (GSK189075)
    • Furosemide
    • Hydrochlorothiazide (HCTZ)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Male subjects who are between 18 and 50 years of age, inclusive.
  • BMI within the range 19-30 kg/m2 (inclusive).
  • Capable of providing signed and dated informed consent, which includes compliance with the requirements and restrictions listed in the consent form and with study-specific instructions provided by the site staff

Exclusion Criteria:

  • Significant renal disease as manifested by one or more of the following:
  • Symptoms of benign prostatic hyperplasia.
  • Prostate-specific antigen level of greater than 10ng/mL (or equivalent to moderately elevated per the local lab).
  • Any medical procedures requiring ingestion of radioactive agents within one week prior to dosing with study drug.
  • Cholecystectomy within 6 months before the first scheduled dose of study drug.
  • Any known or suspected gastrointestinal condition (or minor gastrointestinal surgery within 1 month prior to the first scheduled dose of study drug) that would likely interfere with the absorption or transit of study drug.
  • Any subject with either documented cirrhosis or history consistent with a diagnosis of cirrhosis.
  • History of gout.
  • History of sensitivity to any of the study medications, or their components, which in the opinion of the investigator or GSK Medical Monitor, contraindicates participation.
  • History of allergy to sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, loop diuretics (other than ethacrynic acid).
  • Subjects with clinical laboratory values outside ranges specified in protocol at screening or Day 1:
  • Significant ECG abnormalities at screening according to ranges specified in the protocol:
  • Systolic/Diastolic blood pressure: less than 80/60 mmHg or greater than 150/95 mmHg at screening.
  • Any clinically relevant abnormality identified on the screening physical or laboratory examination.
  • Hemoglobin or hematocrit below the reference range at screening
  • Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
  • The subject has a positive drug/alcohol test at screening or check in into the clinic. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines.
  • History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks/week for men or >7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months prior to screening.
  • A positive test for HIV antibody.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study (whichever is longer): 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • History of sensitivity to latex
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671424

Locations
United States, Ohio
GSK Investigational Site
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00671424     History of Changes
Other Study ID Numbers: KG2105251
Study First Received: April 30, 2008
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Interaction,
Diabetes,
healthy male subjects
GSK189075,
Diuretics,

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Furosemide
Hydrochlorothiazide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Sodium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on September 11, 2014