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

NCT00671424 | Completed Phase 1

• 1 other identifier: KG2105251
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Keywords

Interaction,; Diabetes,; healthy male subjects; GSK189075,; Diuretics,

Outcome Measures

Primary Outcomes (1)

• Serum sodium and potassium concentrations:

  baseline, Day 3, and Days 9-15

Secondary Outcomes (7)

• adverse events:

  each visit

• Physical Exam:

  screening,Days -1,15,follow-up

• ECG & vital signs:

  Days -1,3,8,9,14,15,follow-up

• Clinical labs:screening:

  Days -1,3,8-15,follow-up

• blood pressure:

  days 7,13

Interventions

Hydrochlorothiazide (HCTZ) DRUG

Remogliflozin etabonate (GSK189075) DRUG

Furosemide DRUG

Also known as: Remogliflozin etabonate (GSK189075), Hydrochlorothiazide (HCTZ)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Columbus, Ohio, 43212, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Hydrochlorothiazide; remogliflozin etabonate; Furosemide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfanilamides; Amides; Aniline Compounds; Amines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 5, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: March 19, 2012

Record last verified: 2011-02

Locations

US (1)