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

Condition(s) targeted: Non-Insulin-Dependent Diabetes Mellitus

Intervention: Rosiglitazone (Drug); spironolactone (Drug); hydrochlorothiazide (Drug); frusemide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, DM, FRCP, Study Director, Affiliation: GlaxoSmithKline

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

Official title: 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.

Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Changes in Haematocrit following 7 days diuretic adminstration.

Secondary outcome: Total body fluid & extracellular fluid, body weight, haematocrit & haemoglobin.

Minimum age: 35 Years. Maximum age: 80 Years. Gender(s): Both.

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.

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Starting date: October 2002
Last updated: March 22, 2006