Study In Patients With Insulin Resistance

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197132
First received: September 14, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.

Estimated Enrollment: 18
Study Start Date: October 2002
  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197132

Locations
Netherlands
GSK Clinical Trials Call Center
Nijmegen, Netherlands, 6525EZ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MA GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00197132     History of Changes
Other Study ID Numbers: 49653/375
Study First Received: September 14, 2005
Last Updated: September 14, 2005
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
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014