subjects with impaired fasting glucose (IFG
Conditions
Interventions
Trade Name: Avandia
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Diovan
Pharmaceutical F
Sponsors
VU University Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: One-hundred and forty-four male and female subjects (aged 35-70 years) with impaired fasting glucose (IFG; plasma glucose > or = 6.1 and or = 5.6 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Drug use: current use of ACE-i, ARB and/or TZD's, inability to discontinue these medications; Known hypersensitivity to the study drugs; prior use of blood glucose lowering medications; use of systemic glucocorticoids. Cardiovascular Disease: uncontrolled hypertension requiring ACE-i or ARB; ejection fraction known to be <40% or congestive heart failure, or existing clinical cardiovascular disease. Other criteria: history of DM (except gestational DM); renal or hepatic disease; major illness with life expectancy <5 years; use of other experimental drugs; pregnant; disease/ medications that affect glucose tolerance; unwillingness to be randomized or sign informed consent; known uncontrolled substance abuse; inability to understand study information and/or communicate with clinical staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare beta-cell function, as reflected by the first phase insulin secretion corrected for insulin sensitivity and/or the arginine-stimulated insulin secretion, both co-primary endpoints as measured during the eu-hyperglycemic clamp procedure, following 52 weeks of rosiglitazone, valsartan or rosiglitazone combined with valsartan in subjects with IFG (with and without a family history of DM2) and/or IGT;Secondary Objective: To compare the effects of 52 weeks of rosiglitazone, valsartan or rosiglitazone combined with valsartan in subjects with IFG (with and without a family history of DM2) and/or IGT with respect to: - Fasting plasma glucose - Second phase insulin secretion in response to hyperglycemia during the hyperglycemic clamp test - All the above-mentioned beta-cell function parameters at 12 weeks after discontinuation of therapy to assess durability/disease modifying effects - The conversion from normal glucose tolerance (NGT) to IGT or diabetes (as evaluated by an oral glucose tolerance test) - HbA1c, fasting blood glucose and lipid/lipoprotein concentrations - Insulin sensitivity assessed during the euglycemic clamp test - Safety and tolerability, including assessments of hypoglycemic events, blood pressure, and urinary albumin excretion rate ;Primary end point(s): There are two primary endpoints: 1) The treatment effect on the beta-cell function as measured by the ratio of week 52 first phase insulin secretion (the incremental AUC of insulin with respect to basal value over a 10 minute period, clamp 210-220 min) and 2) the treatment effect on the arginine-stimulated insulin secretion during a hyperglycemic clamp, specifically, the incremental AUC of insulin with respect to basal value over a 10 minute period (i.e. clamp time 290-300 min) to that at baseline (i.e. clamp performed between week -2 and randomization). | — |
Countries
Netherlands
Outcome results
None listed