Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Neuropathy, Diabetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

rosiglitazone

Intervention Type DRUG

Interventions

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rosiglitazone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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Rennings AJ, Smits P, Stewart MW, Tack CJ. Autonomic neuropathy predisposes to rosiglitazone-induced vascular leakage in insulin-treated patients with type 2 diabetes: a randomised, controlled trial on thiazolidinedione-induced vascular leakage. Diabetologia. 2010 Sep;53(9):1856-66. doi: 10.1007/s00125-010-1787-8. Epub 2010 May 25.

Reference Type BACKGROUND

PMID: 20499046 (View on PubMed)

Study Documents

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