Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Rosiglitazone

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