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OpenTrials
Completed

NCT Number: NCT00422955

Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

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

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Key information

Conditions

Neuropathy, Diabetic Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site

Nijmegen, 6525 EZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rosiglitazone

Drug

Primary outcomes

  1. Change in transcapillary escape rate of L125 albumin following 16 weeks treatment

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jan 17, 2007
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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