Fluid Retention in AVANDIA Treated Subjects With Autonomic Neuropathy

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00422955
First received: January 15, 2007
Last updated: October 15, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: AVANDIA (rosiglitazone)
Phase 3

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:


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:
    Drug: AVANDIA (rosiglitazone)
    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
Nervous System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014