Back to results

Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

Primary Purpose

Neuropathy, Diabetic

Status

Completed

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

rosiglitazone

About this trial

This is an interventional treatment trial for Neuropathy, Diabetic focused on measuring fluid retention, Autonomic Neuropathy

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

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.

Full Information

NCT ID

NCT00422955

First Posted

January 15, 2007

Last Updated

September 13, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00422955

Brief Title

Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

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 4mg Twice Daily

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

November 2003 (undefined)

Primary Completion Date

October 2005 (Actual)

Study Completion Date

October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathy, Diabetic

Keywords

fluid retention, Autonomic Neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

rosiglitazone

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Nijmegen

ZIP/Postal Code

6525 EZ

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

20499046

Citation

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.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

49653/376

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

49653/376

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

49653/376

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

49653/376

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

49653/376

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

49653/376

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

49653/376

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

We'll reach out to this number within 24 hrs