Study In Patients With Insulin Resistance

Insulin Resistance Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197132
• Other study ID #: 49653/375
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: December 2, 2016
• Start date: October 2002
• Est. completion date: August 2003

Study information

• Verified date: December 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

Fluid management study in patients with insulin resistance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 (ß-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-? agonist (e.g. rosiglitazone, troglitazone, pioglitazone, G1262570) within the last 4 months or participation in a clinical study involving a TZD or PPAR-? 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-? 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Drug:
• Avandia

Locations

Country	Name	City	State
Netherlands	GSK Clinical Trials Call Center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forearm blood flow			No
Secondary	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.			No

External Links

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