Status:
COMPLETED
Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neuropathy, Diabetic
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
Brief Summary
Fluid management study in patients with type 2 diabetes and autonomic neuropathy.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00422955
Start Date
November 1 2003
End Date
October 1 2005
Last Update
September 15 2016
Active Locations (1)
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1
GSK Investigational Site
Nijmegen, Netherlands, 6525 EZ