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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
History of Changes
  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:

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:
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
 Metabolic Diseases
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 25, 2015