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Type 2 Diabetes MellitusPhase 1NCT00671424

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

A Phase 1 study testing Hydrochlorothiazide (HCTZ), Remogliflozin etabonate (GSK189075) and Furosemide in people with Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
What is being tested?
Hydrochlorothiazide (HCTZ), Remogliflozin etabonate (GSK189075) and Furosemide
How many people
48 participants
Where
1 siteUnited States
Study dates
Mar 2008to May 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 25Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Columbus, Ohio, 43212

Other trials in United States

About this study

Official title: An Evaluation of the Safety, Tolerability, and Pharmacodynamic Effects of GSK189075 When Administered With Furosemide or Hydrochlorothiazide

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.

Being tested
Hydrochlorothiazide (HCTZ), Remogliflozin etabonate (GSK189075), Furosemide
Keywords
Interaction,, Diabetes,, healthy male subjects, GSK189075,, Diuretics,
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydrochlorothiazide (HCTZ)Drug

  • Remogliflozin etabonate (GSK189075)Drug

  • FurosemideDrug

    Also called Remogliflozin etabonate (GSK189075), Hydrochlorothiazide (HCTZ)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum sodium and potassium concentrations:

    Measured: baseline, Day 3, and Days 9-15

Secondary outcomes (7)

  1. adverse events:

    Measured: each visit

  2. Physical Exam:

    Measured: screening,Days -1,15,follow-up

  3. ECG & vital signs:

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

  4. Clinical labs:screening:

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

  5. blood pressure:

    Measured: days 7,13

  6. urine labs:

    Measured: Days 7,8,9,13,14

  7. weight:

    Measured: Days -1,3,4,9,10,15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00671424
Sponsor's protocol ID
KG2105251
Status last verified
Feb 2011
First submitted
30 Apr 2008
Last updated
19 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Hydrochlorothiazide (HCTZ), Remogliflozin etabonate (GSK189075) and Furosemide in people with Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum sodium and potassium concentrations: (time frame: baseline, Day 3, and Days 9-15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00671424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012.

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