Fluid Retention in AVANDIA Treated Subjects With Autonomic Neuropathy

This study has been completed.

First Received on January 15, 2007. Last Updated on October 15, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00422955

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: AVANDIA (rosiglitazone)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double-Blind 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 4 mg bd

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

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.

Estimated Enrollment:	36
Study Start Date:	November 2003

Intervention Details:

Other Name: AVANDIA (rosiglitazone)

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
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

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, MD, Phd

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00422955 History of Changes
Other Study ID Numbers:	49653/376
Study First Received:	January 15, 2007
Last Updated:	October 15, 2008
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:

Autonomic Neuropathy
fluid retention

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Urinary Retention
Nervous System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Urination Disorders
Urologic Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012