Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00422955

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neuropathy, Diabetic	Drug: rosiglitazone	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 4mg Twice Daily

Study Start Date :

Nov 1, 2003

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: rosiglitazone

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: rosiglitazone

Outcome Measures

Primary Outcome Measures

Change in transcapillary escape rate of L125 albumin following 16 weeks treatment []

Secondary Outcome Measures

Change in plasma volume, pedal oedema, extracellular fluid volume following 16 weeks treatment. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.