Last updated: 11/04/2018 03:29:50
Fluid retention in rosiglitazone treated subjects with Autonomic neuropathy.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: Fluid management study in patients with type 2 diabetes and autonomic neuropathy.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change in transcapillary escape rate of L125 albumin following 16 weeks treatment
Timeframe: N/A
Secondary outcomes:
Change in plasma volume, pedal oedema, extracellular fluid volume following 16 weeks treatment.
Timeframe: N/A
Interventions:
Drug: rosiglitazone
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Tack CJJ, Rennings AJM, Stewart MMW, Smits P. Autonomic neuropathy predisposes to rosiglitazone-induced vascular leakage in insulin treated type 2 diabetes. Diabetologia 2007;50(Suppl 1):S37 (abstract 76).
Medical condition
Neuropathy, Diabetic
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
November 2003 to October 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
30 - 75 years
Accepts healthy volunteers
No
- 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
- Subjects with an HbA1c level > 12%
- Subjects taking oral hypoglycaemic agents other than metformin
Inclusion and exclusion 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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-17-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website