Improvement of Insulin Sensitivity by a Novel Drug, BGP-15, in Insulin-resistant Patients: A Proof of Concept Randomized Double-blind Clinical Trial

• DOI: 10.1055/s-0028-1128142
• Publication Date: 2009-02-13T01:53:15Z
• Authors: B. Literáti-Nagy; E. Kulcsár; Zs. Literáti-Nagy; B. Buday; É. Péterfai; T. Horváth; K. Tory; A. Kolonics; A. Fleming; J. Mandl; L. Korányi
• Keywords: Adult; Male; 0303 health sciences; Drug-Related Side Effects and Adverse Reactions; Middle Aged; 3. Good health; Placebos; Young Adult; 03 medical and health sciences; Glucose; Double-Blind Method; Piperidines; Glucose Intolerance; Oximes; Humans; Hypoglycemic Agents; Insulin; Female; Insulin Resistance

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.