NDLI: Safety, efficacy and weight effect of two 11ß-HSD1 inhibitors in metformin-treated patients with type 2 diabetes.

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Safety, efficacy and weight effect of two 11ß-HSD1 inhibitors in metformin-treated patients with type 2 diabetes.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Heise, T. Morrow, L. Hompesch, M. Häring, H-U Kapitza, C. Abt, M. Ramsauer, M. Magnone, M-C Fuerst-Recktenwald, S.
Spatial Coverage	United States Austria Germany
Description	Country affiliation: Germany Author Affiliation: Heise T ( Profil, Neuss, Germany.)
Abstract	AIMS: We assessed safety and efficacy of two selective 11ß-HSD1 inhibitors (RO5093151/RO-151 and RO5027383/RO-838) in this randomized, controlled study in metformin-treated patients with type 2 diabetes. METHODS: Patients either received placebo (N = 21), RO-151 BID 5 mg (N = 24) or 200 mg (N = 20) or RO-838 QD 50 mg (N = 21) or 200 mg (N = 24) for 28 days. Metabolic assessments comprising of nine-point plasma glucose profiles, oral glucose tolerance tests and determination of metabolic biomarkers including insulin, C-peptide, glucagon, HbA1c and lipids were done at baseline and end of treatment. RESULTS: Despite the short treatment duration, both RO-151 and RO-838 showed trends for improved HbA1c and consistent reductions in body weight (-0.86 to -1.67 kg) exceeding those observed with placebo (-0.28 kg, p = 0.019 for 200 mg RO-151 vs. placebo). Insulin sensitivity parameters (e.g. HOMA-IR and Matsuda-Index) improved non-significantly with 200 mg RO-151. Lipid parameters did not consistently improve with either compound, but RO-838 led to non-significant increases in triglycerides and VLDL-cholesterol versus placebo. Both compounds were well tolerated and showed inhibitory effects on 11ß-HSD1 activity based on urinary corticosteroid excretion. As reported for other 11ß-HSD1-inhibitors increased concentrations of ACTH and adrenal androgen precursors were found with RO-151, but not with RO-838. CONCLUSIONS: Slight metabolic improvements were seen, in particular with RO-151 high dose, however, the observed changes often did not reach statistical significance and were not clearly dose dependent. Studies of longer duration are needed to further investigate potential benefits and risks of these compounds.
File Format	HTM / HTML
ISSN	14628902
Issue Number	11
Volume Number	16
e-ISSN	14631326
Journal	Diabetes, Obesity and Metabolism
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2014-11-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Metabolism Discipline Endocrinology Discipline Pharmacology Discipline Diabetology 11-beta-hydroxysteroid Dehydrogenase Type 1 Antagonists & Inhibitors Blood Glucose Drug Effects Body Weight Diabetes Mellitus, Type 2 Drug Therapy Hemoglobin A, Glycosylated Hypoglycemic Agents Therapeutic Use Metformin Adult Aged Austria Metabolism C-peptide Blood Dose-response Relationship, Drug Double-blind Method Female Germany Glucose Tolerance Test Humans Insulin Lipids Male Middle Aged Risk Assessment Treatment Outcome United States Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Endocrinology, Diabetes and Metabolism Internal Medicine Endocrinology

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