Fluid Retention in AVANDIA Treated Subjects With Autonomic Neuropathy
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: AVANDIA (rosiglitazone) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Phd, Principal Investigator, Affiliation: GlaxoSmithKline
Summary
Fluid management study in patients with type 2 diabetes and autonomic neuropathy.
Clinical Details
Official title: A 16-Week, Randomised, Double-Blind, Placebo-Controlled, Single-Centre Study to Investigate Fluid Retention in Insulin-Treated Subjects With Type 2 Diabetes Mellitus and Varying Degrees of Autonomic Neuropathy When Administered Rosiglitazone 4 mg bd
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
Primary outcome: Change in transcapillary escape rate of L125 albumin following 16 weeks treatment
Secondary outcome: Change in plasma volume, pedal oedema, extracellular fluid volume following 16 weeks treatment.
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
Subjects with Type 2 Diabetes (T2DM) as defined by the 1999 WHO criteria [World Health
Organisation , 1988/NCD/NCS/99. 2] with stable FPG of = 7. 0 and = 15. 0 mmol/l who have been
established on insulin therapy for at least 6 months
BMI = 40 kg. m2
Subject who is willing and able to provide a signed and dated written informed
consent.
Exclusion Criteria:
Subjects with an HbA1c level > 12%
Subjects taking oral hypoglycaemic agents other than metformin
Subjects on insulin dosage > 200 units/day
Locations and Contacts
GSK Clinical Trials Call Center, Nijmegen 6525, Netherlands
Additional Information
Starting date: October 2004
Last updated: January 15, 2007
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