Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Neuropathy, Diabetic

Treatments: Drug: rosiglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422955

49653/376

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: rosiglitazone