Improvement of insulin sensitivity by a novel drug, BGP-15, in insulin-resistant patients: a proof of concept randomized double-blind clinical trial.
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.
Literáti-Nagy
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B
Drug Research Center Ltd., 8230 Balatonfüred, Ady Endre u. 12, Hungary. botond.literati@drc.hu
Kulcsár
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E
Literáti-Nagy
Zs
Z
Buday
B
B
Péterfai
E
E
Horváth
T
T
Tory
K
K
Kolonics
A
A
Fleming
A
A
Mandl
J
J
Korányi
L
L
D000328:Adult; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005947:Glucose / Q000378:metabolism; D018149:Glucose Intolerance / Q000188:drug therapy* / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000378:metabolism*; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D010091:Oximes / Q000008:administration & dosage*; D010880:Piperidines / Q000008:administration & dosage*; D010919:Placebos; D055815:Young Adult
D007004:Hypoglycemic Agents; D007328:Insulin; D010091:Oximes; D010880:Piperidines; D010919:Placebos; D005947:Glucose; C405586:BGP 15