Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-02-23 @ 1:37 PM
Study NCT ID:
NCT00197132
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2005-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study In Patients With Insulin Resistance
Sponsor:
Organization:
Raw JSON
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BMI = Weight/height², (where weight is in kg, height in m).\n* Male or female aged 30 to 65 years, inclusive, at screening.\n* 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.\n* Willing and able to provide a signed and dated written informed consent.\n\nExclusion Criteria:\n\n* 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.\n* 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.\n* 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.\n* 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.\n* Subjects who have required the use of any anti-diabetic medication at any time.\n* Use of any investigational drug within 30 days preceding the first dose of medication at the start of the study.\n* Subjects with a documented history of significant hypersensitivity (e.g. difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to thiazolidinediones or PPAR-γ agonists.\n* Systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg or receiving antihypertensive therapy.\n* Subjects with unstable or severe angina (requiring continual therapy) or congestive heart failure.\n* Presence of clinically significant hepatic disease.\n* Clinically significant anaemia.\n* Subjects with creatinine clearance \\<40 mL/min.\n* Women who are lactating, pregnant or planning to become pregnant during the course of the study.\n* Alcohol or drug abuse within the last 6 months.'}, 'identificationModule': {'nctId': 'NCT00197132', 'briefTitle': 'Study In Patients With Insulin Resistance', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '49653/375'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Avandia', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525EZ', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}