Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy. - Full Text View

Purpose

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

Condition	Intervention	Phase
Neuropathy, Diabetic	Drug: rosiglitazone	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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.


Enrollment:	36
Study Start Date:	November 2003
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: rosiglitazone

Eligibility


Ages Eligible for Study:	30 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00422955

Locations


Netherlands
GSK Investigational Site
Nijmegen, Netherlands, 6525 EZ

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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