Article

Improvement of insulin sensitivity by a novel drug, BGP-15, in insulin-resistant patients: a proof of concept randomized double-blind clinical trial.

Drug Research Center Ltd., 8230 Balatonfüred, Ady Endre u. 12, Hungary.
Hormone and Metabolic Research (impact factor: 2.19). 03/2009; 41(5):374-80. DOI:10.1055/s-0028-1128142 pp.374-80
Source: PubMed

ABSTRACT The efficacy and safety of the new drug, BGP-15, were compared with placebo in insulin-resistant patients in a 28-day dose-ranging study. Forty-seven nondiabetic patients with impaired glucose tolerance were randomly assigned to 4 weeks of treatment with 200 or 400 mg of BGP-15 or placebo. Insulin resistance was determined by hyperinsulinemic euglycemic clamp technique and homeostasis model assessment method, and beta-cell function was measured by intravenous glucose tolerance test. Each BGP-15 dose significantly increased whole body insulin sensitivity (M-1, p=0.032), total body glucose utilization (M-2, p=0.035), muscle tissue glucose utilization (M-3, p=0.040), and fat-free body mass glucose utilization (M-4, p=0.038) compared to baseline and placebo. No adverse drug effects were observed during treatment. BGP-15 at 200 or 400 mg significantly improved insulin sensitivity in insulin-resistant, nondiabetic patients during treatment compared to placebo and was safe and well-tolerated. This was the first clinical study demonstrating the insulin-sensitizing effect of a molecule, which is considered as a co-inducer of heat shock proteins.

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    Article: A Novel Insulin Sensitizer Drug Candidate-BGP-15-Can Prevent Metabolic Side Effects of Atypical Antipsychotics.
    Zsuzsanna Literati-Nagy, Kálmán Tory, Botond Literáti-Nagy, Attila Kolonics, László Vígh, József Mandl, Zoltán Szilvássy
    [show abstract] [hide abstract]
    ABSTRACT: Atypical antipsychotic drugs (AAPD) are widely used to treat severe psychiatric disorders, have well documented metabolic side effects such as disturbances in glucose metabolism, insulin resistance and weight gain. It has been shown that BGP-15, a hydroxylamine derivative with insulin sensitizing activity can prevent AAPD provoked fat accumulation in adipocyte cultures, and insulin resistance in animal experiments and in healthy volunteers. The aim of this study was to compare the preventive effect of BGP-15 with conventional oral antidiabetics on metabolic side effects of AAPDs. We found that BGP-15 that does not belong to either conventional insulin sensitizers or oral antidiabetics, is able to counteract insulin resistance and weight gain provoked by antipsychotic agents in rats while rosiglitazone and metformin were not effective in the applied doses. Our results confirm that BGP-15 is a promising new drug candidate to control the metabolic side effects of atypical antipsychotics. Data indicate that this rat model is suitable to analyze the metabolic side effects of AAPDs and the protective mechanism of BGP-15.
    Pathology & Oncology Research 06/2012; 18(4):1071-6. · 1.37 Impact Factor
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Keywords

28-day dose-ranging study
 
4 weeks
 
adverse drug effects
 
beta-cell function
 
BGP-15 dose
 
fat-free body mass glucose utilization
 
first clinical study
 
glucose tolerance
 
heat shock proteins
 
homeostasis model assessment method
 
hyperinsulinemic euglycemic clamp technique
 
insulin-resistant
 
insulin-resistant patients
 
insulin-sensitizing effect
 
intravenous glucose tolerance test
 
muscle tissue glucose utilization
 
new drug
 
placebo
 
total body glucose utilization