Last updated: 11/07/2018 14:56:30
Study In Patients With Insulin Resistance
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A single-centre, randomised, double-blind, placebo controlled, two 12 week period, cross-over phase III study to investigate the effect of rosiglitazone 4mg bd on the vasodilator response to hyperinsulinaemia in obese insulin resistant subjects.
Trial description: Fluid management study in patients with insulin resistance.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Avandia
Enrollment:
18
Observational study model:
Not applicable
Primary completion date:
2003-31-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Insulin resistance
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
October 2002 to August 2003
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
30 - 65 years
Accepts healthy volunteers
No
- BMI 27-36 kg/m2 inclusive and at least two additional features of the metabolic
- syndrome or a first degree relative with
- Subjects with type 2 diabetes mellitus defined as an HbA1c level >6.5% or a fasting
- plasma glucose of > 7.0 mmol/L. If fasting plasma glucose is between 6.1 and 7.0
Inclusion and exclusion criteria
Inclusion criteria:
- BMI 27-36 kg/m2 inclusive and at least two additional features of the metabolic syndrome or a first degree relative with a history of type 2 diabetes mellitus. BMI = Weight/height², (where weight is in kg, height in m).
- Male or female aged 30 to 65 years, inclusive, at screening.
- Female subjects must be post-menopausal (i.e. >6 months without menstrual period), surgically sterile, or using effective contraceptive measures (oral contraceptives, Norplant Depo-Provera) or intra-uterine devices (IUD) (a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures for at least 1 month prior to visit 1, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study treatment.
- Willing and able to provide a signed and dated written informed consent.
Exclusion criteria:
- Subjects with type 2 diabetes mellitus defined as an HbA1c level >6.5% or a fasting plasma glucose of > 7.0 mmol/L. If fasting plasma glucose is between 6.1 and 7.0 mmol/L then a 75 g oral glucose test will be performed to exclude diabetes mellitus.
- Subjects who have initiated lipid lowering therapy within the last 6 months and subjects who have increased the dose of these therapies within the last 3 months prior to study start.
- Subjects who are taking Non Steroidal Anti-inflammatory Drugs, fibrates, anticoagulants or cardiovascular medications (β-blockers, nitrates, calcium antagonists, ACE inhibitors, angiotensin II antagonists, alpha blockers, diuretics, centrally acting anti-hypertensives, directly acting antihypertensives e.g., diazoxide, digoxin, anti-arrhythmics) and are unable to stop these medications for the duration of the study.
- Exposure to a thiazolidinedione (TZD) or other PPAR-γ agonist (e.g. rosiglitazone, troglitazone, pioglitazone, G1262570) within the last 4 months or participation in a clinical study involving a TZD or PPAR-γ agonist.
- Subjects who have required the use of any anti-diabetic medication at any time.
- Use of any investigational drug within 30 days preceding the first dose of medication at the start of the study.
- Subjects with a documented history of significant hypersensitivity (e.g. difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to thiazolidinediones or PPAR-γ agonists.
- Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg or receiving antihypertensive therapy.
- Subjects with unstable or severe angina (requiring continual therapy) or congestive heart failure.
- Presence of clinically significant hepatic disease.
- Clinically significant anaemia.
- Subjects with creatinine clearance <40 mL/min.
- Women who are lactating, pregnant or planning to become pregnant during the course of the study.
- Alcohol or drug abuse within the last 6 months.
Trial location(s)
Location
GSK Clinical Trials Call Center
Nijmegen, N/A, Netherlands, 6525EZ
Status
Study Complete
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
2003-31-08
Actual study completion date
2003-31-08
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
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