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
Study complete
Study complete
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:
Enrollment:
36
Primary completion date:
Not applicable
Observational study model:
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
- Inclusion criteria:
- Subjects with Type 2 Diabetes (T2DM) as defined by the 1999 WHO criteria [World Health
Inclusion and exclusion criteria
Inclusion 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
Study complete
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.
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