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Study In Patients With Insulin Resistance

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: September 14, 2005
Last updated: April 10, 2015
Last verified: April 2015
Fluid management study in patients with insulin resistance.

Condition Intervention Phase
Insulin Resistance
Drug: Avandia
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Forearm blood flow

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.

Enrollment: 18
Study Start Date: October 2002
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00197132

GSK Clinical Trials Call Center
Nijmegen, Netherlands, 6525EZ
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MA GlaxoSmithKline
  More Information Identifier: NCT00197132     History of Changes
Other Study ID Numbers: 49653/375 
Study First Received: September 14, 2005
Last Updated: April 10, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:
Insulin resistance vasodilatory response

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on October 28, 2016