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DOI: 10.1055/s-0028-1128142
© Georg Thieme Verlag KG Stuttgart · New York
Improvement of Insulin Sensitivity by a Novel Drug, BGP-15, in Insulin-resistant Patients: A Proof of Concept Randomized Double-blind Clinical Trial
Publikationsverlauf
received 10.09.2008
accepted 10.12.2008
Publikationsdatum:
12. Februar 2009 (online)
![](https://www.thieme-connect.de/media/hmr/200905/lookinside/thumbnails/10.1055-s-0028-1128142-1.jpg)
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 β-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.
Key words
BGP-15 - insulin resistance - heat shock protein inducer - hyperinsulinemic euglycemic clamp - glucose utilization
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