Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

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 4mg Twice Daily

Fluid management study in patients with type 2 diabetes and autonomic neuropathy.

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