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Examining the Effect of Different Diuretics on Fluid Retention in Diabetics Treated With Rosiglitazone.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00306696
First received: March 22, 2006
Last updated: October 25, 2012
Last verified: March 2011
  Purpose

Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.


Condition Intervention Phase
Non-Insulin-Dependent Diabetes Mellitus
Diabetes Mellitus
Drug: Rosiglitazone
Drug: spironolactone
Drug: hydrochlorothiazide
Drug: frusemide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Changes in Haematocrit following 7 days diuretic adminstration.

Secondary Outcome Measures:
  • Total body fluid & extracellular fluid, body weight, haematocrit & haemoglobin.

Estimated Enrollment: 388
Study Start Date: October 2002
Intervention Details:
    Drug: Rosiglitazone Drug: spironolactone Drug: hydrochlorothiazide Drug: frusemide
    Other Names:
    • spironolactone
    • hydrochlorothiazide
    • Rosiglitazone
    • frusemide
Detailed Description:

A randomised, open-label, parallel group study to evaluate the management of rosiglitazone-related fluid retention by investigating the effect of diuretics on plasma volume in subjects with type 2 diabetes mellitus treated for twelve weeks with rosiglitazone 4mg bd in addition to background anti-diabetic agents.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subjects with type 2 diabetes.
  • Stable FPG of >=7.0 and <=12.0mmol/L.
  • Subjects had to have been established on SU treatment or SU+MET treatment for at least 2 months.
  • Serum creatinine level > 130 micromol/L.

Exclusion criteria:

  • Subjects taking > 2 concomitant oral anti-diabetic agents.
  • Subjects with HbA1c >=10%.
  • Subjects already receiving diuretic medication.
  • Subjects unstable or severe angina.
  • CHF NYHA class i-iv.
  • Subjects with clinically significant hepatic disease.
  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: NCT00306696

  Show 44 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00306696     History of Changes
Other Study ID Numbers: 49653/342
Study First Received: March 22, 2006
Last Updated: October 25, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
rosiglitazone
fluid retention
Type 2 diabetes
diuretics

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

ClinicalTrials.gov processed this record on November 25, 2014