Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.
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ClinicalTrials.gov Identifier: NCT00422955 |
Recruitment Status
:
Completed
First Posted
: January 17, 2007
Last Update Posted
: September 15, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuropathy, Diabetic | Drug: rosiglitazone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
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 4mg Twice Daily |
Study Start Date : | November 2003 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 | Drug: rosiglitazone |
- Change in transcapillary escape rate of L125 albumin following 16 weeks treatment
- Change in plasma volume, pedal oedema, extracellular fluid volume following 16 weeks treatment.

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Ages Eligible for Study: | 30 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422955
Netherlands | |
GSK Investigational Site | |
Nijmegen, Netherlands, 6525 EZ |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Annotated Case Report Form

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

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

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

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

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

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

For additional information about this study please refer to the GSK Clinical Study Register
Publications:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00422955 History of Changes |
Other Study ID Numbers: |
49653/376 |
First Posted: | January 17, 2007 Key Record Dates |
Last Update Posted: | September 15, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Keywords provided by GlaxoSmithKline:
fluid retention Autonomic Neuropathy |
Additional relevant MeSH terms:
Peripheral Nervous System Diseases Nervous System Diseases Edema Diabetic Neuropathies Neuromuscular Diseases Signs and Symptoms |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs |