Study In Patients With Insulin Resistance

Phase 3

Completed

• Conditions: Insulin Resistance

• Registration Number: NCT00197132
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Fluid management study in patients with insulin resistance.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Forearm blood flow

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

GSK Clinical Trials Call Center; 🇳🇱 Nijmegen, Netherlands