Study In Patients With Insulin Resistance
Overview[ - collapse ][ - ]
| Purpose | Fluid management study in patients with insulin resistance. |
|---|---|
| Condition | Insulin Resistance |
| Intervention | Drug: Avandia |
| Phase | Phase 3 |
| Sponsor | GlaxoSmithKline |
| Responsible Party | GlaxoSmithKline |
| ClinicalTrials.gov Identifier | NCT00197132 |
| First Received | September 14, 2005 |
| Last Updated | September 14, 2005 |
| Last verified | September 2005 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 14, 2005 |
|---|---|
| Last Updated Date | September 14, 2005 |
| Start Date | October 2002 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Forearm blood flow |
| Current Secondary Outcome Measures | Insulin sensitivity, plasma volume, transcapillary escape rate, inhibition to vasodialtory response, changes in cardiac output, plasma catecholamine levels, changes in plasma hormone/markers of vascular permeability, safety and tolerability. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Study In Patients With Insulin Resistance |
|---|---|
| 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. |
| Brief Summary | Fluid management study in patients with insulin resistance. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Insulin Resistance |
| Intervention | Drug: Avandia |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 18 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility 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. |
| Gender | Both |
| Ages | 30 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Netherlands |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00197132 |
|---|---|
| Other Study ID Numbers | 49653/375 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | GlaxoSmithKline |
| Study Sponsor | GlaxoSmithKline |
| Collaborators | Not Provided |
| Investigators | Study Director: GSK Clinical Trials, MA GlaxoSmithKline |
| Verification Date | September 2005 |
Locations[ + expand ][ + ]
| GSK Clinical Trials Call Center | Nijmegen, Netherlands, 6525EZ |
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