Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

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ClinicalTrials.gov Identifier: NCT00422955

Recruitment Status : Completed

First Posted : January 17, 2007

Last Update Posted : September 15, 2016

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

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 (Clinical Trial)
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 :	November 2003
Actual Primary Completion Date :	October 2005
Actual Study Completion Date :	October 2005

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Type 2 diabetes

MedlinePlus related topics: Edema

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Arms and Interventions

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

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Ages Eligible for Study:	30 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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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