Horm Metab Res 2009; 41(5): 374-380
DOI: 10.1055/s-0028-1128142
Humans, Clinical

© 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

B. Literáti-Nagy 1 , E. Kulcsár 1 , Zs. Literáti-Nagy 2 , B. Buday 1 , É. Péterfai 1 , T. Horváth 1 , K. Tory 2 , A. Kolonics 2 , A. Fleming 3 , J. Mandl 4 , L. Korányi 1
  • 1DRC (Drug Research Center) Ltd., Balatonfüred, Hungary
  • 2N-Gene Research Laboratories Inc., Budapest, Hungary
  • 3Kinexum Science Medicine Industry, Harper's Ferry, USA
  • 4Department of Medical Chemistry, Molecularbiology and Pathobiochemistry Semmelweis University Budapest, Budapest
Further Information

Publication History

received 10.09.2008

accepted 10.12.2008

Publication Date:
12 February 2009 (eFirst)

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.

References

Correspondence

B. Literáti-Nagy, MD 

DRC (Drug Research Center) Ltd.

8230 Balatonfüred

Ady Endre u. 12

Hungary

Phone: +36/87/48 16 16

Fax: +36/87/58 01 16

Email: botond.literati@drc.hu