Status:
COMPLETED
Study In Patients With Insulin Resistance
Lead Sponsor:
GlaxoSmithKline
Conditions:
Insulin Resistance
Eligibility:
All Genders
30-65 years
Phase:
PHASE3
Brief Summary
Fluid management study in patients with insulin resistance.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00197132
Start Date
October 1 2002
End Date
August 1 2003
Last Update
December 5 2016
Active Locations (1)
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1
GSK Clinical Trials Call Center
Nijmegen, Netherlands, 6525EZ